A Low-birthweight Baby Is Defined as One Who Weighs Less Than 5 1/2 Pounds.
Vaccine. 2017 Dec four; 35(48Part A): 6492–6500.
Low birth weight: Instance definition & guidelines for data drove, analysis, and presentation of maternal immunization safe data
Clare L. Cutland
aMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, S Africa
bDepartment of Scientific discipline and Engineering science National Research Foundation, Vaccine Preventable Diseases, South Africa
cKinesthesia of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Eve Thousand. Lackritz
dGlobal Alliance to Prevent Prematurity and Stillbirth (GAPPS), Seattle Children's Enquiry Institute, Seattle, WA, USA
Tamala Mallett-Moore
eSanofi Pasteur Inc., Swiftwater, PA, USA
Azucena Bardají
fISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Infirmary Clínic – Academy of Barcelona, Barcelona, Espana
Ravichandran Chandrasekaran
gMadras Medical College, India
Chandrakant Lahariya
hDepartment of Community Medicine, GR Medical College and Associated Hospitals, Gwalior, MP, India
Muhammed Imran Nisar
iDepartment of Pediatrics and Child Wellness, Aga Khan University, Karachi, Pakistan
Milagritos D. Tapia
jUniversity of Maryland School of Medicine, Center for Vaccine Development, MD, United states
Jayani Pathirana
aMedical Research Quango: Respiratory and Meningeal Pathogens Research Unit of measurement, Johannesburg, South Africa
bDepartment of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Due south Africa
cKinesthesia of Health Sciences, University of the Witwatersrand, Johannesburg, Due south Africa
Sonali Kochhar
kGlobal Healthcare Consulting, India
thouErasmus University Medical Center, Rotterdam, The Netherlands
Flor K. Muñoz
50Baylor College of Medicine, Departments of Pediatrics, Molecular Virology and Microbiology, Houston, TX, United states
Keywords: Low nascency weight, Adverse event, Immunization, Guidelines, Instance definition
1. Preamble
1.1. Need for developing instance definitions and guidelines for information collection, analysis, and presentation for low birth weight as an adverse event following maternal immunization
The birth weight of an infant is the first weight recorded later on birth, ideally measured within the beginning hours after nascence, before pregnant postnatal weight loss has occurred. Low nascency weight (LBW) is defined as a birth weight of less than 2500 thousand (upwardly to and including 2499 g), every bit per the World Wellness Organization (WHO) [1]. This definition of LBW has been in existence for many decades. In 1976, the 29th World Health Assembly agreed on the currently used definition. Prior to this, the definition of LBW was '2500 g or less'. Low nativity weight is further categorized into very low birth weight (VLBW, <1500 g) and extremely low birth weight (ELBW, <m 1000) [1]. Depression nascence weight is a result of preterm birth (PTB, brusque gestation <37 completed weeks), intrauterine growth brake (IUGR, also known as fetal growth restriction), or both.
The term depression nascency weight refers to an absolute weight of <2500 m regardless of gestational age. Pocket-sized for gestational age (SGA) refers to newborns whose nascence weight is less than the tenth percentile for gestational historic period. This report will focus specifically on birth weight <2500 grand. Further details related to example definitions for PTB [2], IUGR and SGA are included in separate GAIA reports.
Globally, it is estimated that 15–20% of all births, or >xx million newborns annually, are low birth weight infants. Low- and heart-income countries business relationship for a disproportionate burden of LBW; over 95% of the world's LBW infants are born in LMICs. There are marked global and regional variations in LBW rates. An estimated half-dozen% of infants are built-in LBW in E Asia and the Pacific, 13% in Sub-Saharan Africa, and up to 28% in Southern asia [3]. Up to half of all LBW infants are built-in in south asia [four]. Loftier-income regions study lower LBW rates, including 6.nine% from UK [5]. Of business organization is the estimated increase in LBW rates in certain middle-income countries such as Sultanate of oman, where the LBW rate went from iv% in 1980 to eight.i% in 2000 [6].
One of the major challenges in monitoring the incidence of LBW is that more than than half of infants in the LMICs are not weighed [7]. Population-based survey information ofttimes rely on modeled estimates, with statistical methods to adjust for underreporting and misreporting of birth weight. In the context of vaccine safety monitoring, accurate ascertainment of birth weight in LMICs will continue to crave attention and investment to improve accuracy and reporting of this of import health indicator.
i.1.1. Why are nosotros concerned about low nascence weight?
Low birth weight is a valuable public health indicator of maternal health, diet, healthcare commitment, and poverty. Neonates with low nascence weight take a >xx times greater chance of dying than neonates with birth weight of >2500 g [viii], [ix]. Additionally, depression birth weight is associated with long-term neurologic disability, impaired language development [10], impaired academic achievement, and increased risk of chronic diseases including cardiovascular disease and diabetes. Preterm infants carry boosted risk due to immaturity of multiple organ systems, including intracranial hemorrhage, respiratory distress, sepsis, blindness, and gastrointestinal disorders. Preterm birth is the leading crusade of all under-five child mortality worldwide [11].
In add-on, economic studies in low-income settings have demonstrated that reducing the brunt of low birth weight would accept important toll savings both to the wellness system and to households [12].
1.1.2. What leads to low nativity weight?
The underlying causes of both PTB and IUGR are multifactorial, and the biological pathways and preventive strategies for these two weather are quite different [13], [14], [15]. The exact crusade of PTB may exist unknown in many cases, however numerous maternal, fetal and placental factors may contribute to PTB [13]. Pregnant maternal atmospheric condition include extra-uterine infection, chorioamnionitis, trauma and affliction (e.chiliad. pre-eclampsia/eclampsia). Significant fetal conditions include IUGR, fetal infection, expiry and anomalies. Placental pathologic weather condition include placental abruption and placenta praevia [xiii].
In full general, the causes of IUGR can be due to maternal, fetal, and placental factors. Although the etiologies are different, they frequently have the final common pathway of bereft uterine-placental perfusion and fetal nutrition.
IUGR can be asymmetrical IUGR (where babies have features of malnutrition), symmetrical IUGR (hypoplastic small-scale for dates) or mixed IUGR. Asymmetrical IUGR is the almost common (seventy–eighty%) form of IUGR, resulting from an insult (oft utero-placental insufficiency) later in pregnancy, which results in affected babies having normal length and head circumference (brain sparing), but reduced weight. Symmetrical IUGR on the other mitt arises from an insult (often genetic, structural or infectious) occurring before in pregnancy leading to a reduction in all anthropometric parameters in fetus/newborn [15].
Insufficient perfusion, through abnormal placentation, aberrant placental vascularization, maternal hypertensive disorders, and tobacco apply, all consequence in IUGR. Multiple gestation (i.e., twins, triplets) is associated with increased chance of both IUGR and PTB [16]. Infectious diseases, including intrauterine infections, HIV, and malaria, event in LBW due to both growth restriction and short gestation. Multiple maternal characteristics, risk behaviors, and social determinants are associated with both IUGR and PTB; these include maternal brusk stature, maternal malnutrition, low trunk mass index, poverty, black race, narrow kid spacing, low maternal education, poor antenatal intendance, substance abuse, and emotional and physical stress [5], [17], [18], [xix]. How these factors are mediated biologically remains poorly understood.
Preterm birth may exist spontaneous or medically-indicated, such as induction or cesarean section for maternal complications such as pre-eclampsia. Infectious and inflammatory processes are associated with increased risk for PTB, including chorioamnionitis, bacterial vaginosis, bacteriuria, and systemic or remote site infection such as sepsis and periodontal disease.
one.1.3. The importance of brusk gestation on immune function and vaccine efficacy
Transplacental antibiotic transfer is an agile process mediated past Fc receptors in the placental syncytiotrophoblast [20], which increases from 30 weeks gestation. Minor molecular weight particles (<600 Da) cross the placenta by passive mechanism including diffusion, however, larger molecular weight particles (>m Da) are transported across the placenta by and active receptor-mediated process [21]. Fetal IgG levels are approximately 50% of maternal antibody level at 32 weeks gestation and rises chop-chop through the third trimester [22]. Preterm newborns have significantly lower antibiotic levels than term newborns [22]. LBW term newborns have significantly lower antibody concentrations to Canker simplex virus type i, respiratory syncytial virus advert varicella zoster virus than term newborns with nativity weight >2500 g [23].
Maternal antibody levels, receptor density and functionality, ardor, antigen nature, and gestational age determine the efficiency of placental antibody transfer [24]. Diseases that are highly prevalent in some areas, such equally malaria and human immunodeficiency virus (HIV), are known to cause placental impairment, especially placental malaria [25], [26]. Maternal HIV infection has been consistently associated with reduced placental passage of antibodies against several common viral and bacterial antigens [27], [28]. Placental malaria has been associated with maternal hypergammaglobulinemia and reduced transfer of antibodies against measles virus, Clostridium tetani, Streptococcus pneumonia, and varicella-zoster virus in some studies [20], [29], [xxx], [31]. The transfer during pregnancy of maternal antibodies to the fetus minimizes deficiencies in antibiotic product in the fetus and provides short-term passive amnesty [32], conditioning the success of vaccination in newborns [33] which is particularly of import in preterm and IUGR newborns. Multiple comorbidities are associated with both LBW and immune suppression, such as malnutrition and infection, thereby further exacerbating diminished immune part in the compromised newborn.
ane.1.4. Maternal immunization and nascency weight
Maternal infections, including flu, have been associated with increased run a risk of low birth weight newborns [34]. Every bit a corollary, prevention of certain infections during pregnancy might take a protective consequence against LBW. This has been observed in a maternal immunization trial conducted in Bangladesh [35], in which the mean birth weight of infants born to mothers who received an inactivated influenza vaccine during pregnancy was higher than of infants built-in to mothers who received a pneumococcal polysaccharide vaccine (3178 g vs. 2978 g, p = 0.02). This trend has non been observed in other maternal influenza immunization trials [36].
The field of immunization of pregnant women has highlighted the importance of knowing background rates of adverse pregnancy events, including LBW, PTB, SGA, IUGR, stillbirths, and neonatal death, which can vary markedly between and within regions. The greatest bear on of illness prevention from maternal immunization is expected to be observed in LMIC, where the burden of disease is greatest and access to health care services is most limited. For this reason, item attention is being given to advancing maternal immunization trials in LMICs. Unfortunately, reliable, accurate, and timely reports of vital statistics and demographic information are often limited in these settings.
Data Rubber Monitoring Boards are established to review clinical trial data, including regular assessment or review of adverse result rates in trial participants. Without accurate information on background rates of low birthweight and other agin pregnancy outcomes, information technology volition exist impossible to observe an increase in adverse events following immunization. Evolution of standardized methods to collect and report LBW and other essential outcomes will exist essential to advancing maternal immunization programs worldwide.
Nascency weight is usually included nether demographics of trial participant infants, and the differences in birth weights between participants enrolled in agile and placebo or control arms of interventional trials in pregnancy are usually assessed.
The LBW Working Group recommends apply of traditional case definitions of LBW as defined by the World Wellness Arrangement. This study therefore focuses on delineating data quality related to methods used to estimate birth weight in LMICs, and summarizes some surrogate measurements that are under investigation to assess birth weight and estimate population-level background LBW rates.
i.2. Methods for the review of the case definition and guidelines for information collection, analysis, and presentation for low birth weight in clinical trial and population settings
Post-obit the process described in the overview paper [21] as well equally on the Brighton Collaboration Website http://www.brightoncollaboration.org/internet/en/index/process.html, the Brighton Collaboration Low nativity weight Working Group was formed in 2016 and included sixteen members of varied backgrounds including clinical, academic, public health and industry. The composition of the working and reference group likewise every bit results of the web-based survey completed by the reference grouping with subsequent discussions in the working grouping tin be viewed at: http://world wide web.brightoncollaboration.org/internet/en/index/working_groups.html.
To guide the decision-making for the guidelines, a literature search was performed using Medline/PubMed, Embase, ClinicalKey (ebooks), ScienceDirect (eBooks), eBrary (eBooks) and the Cochrane Libraries, including the terms: 'pregnancy, vaccines and low nascency weight', and restricted to English language publications since 2005. The search resulted in the identification of 41 references. All abstracts were screened for possible reports of Low nascence weight following immunization. Thirty-two articles with potentially relevant material were reviewed in more detail, in guild to identify studies using case definitions or, in their absenteeism, providing clinical descriptions of the example material. This review resulted in a detailed summary of xix articles, including information on the study type, the vaccine, the diagnostic criteria or instance definition put forth, the fourth dimension interval since fourth dimension of immunization, and any other symptoms. Multiple general medical, pediatric and communicable diseases book chapters were also searched.
The definition of low birth weight used was consequent across all literature reviewed.
A 2d literature search using the search terms 'birth weight and tools' was performed using Pubmed, to identify other measurements used as proxies for nativity weight. The search, unrestricted for language and yr of publication, identified in 235 results. Titles were screened and 10 articles were identified for further review.
1.3. Rationale for selected decisions nigh the instance definition of low nascency weight as an adverse event post-obit maternal immunization
i.3.1. The term depression birth weight
'Low birth weight' (LBW) has been divers as first weight recorded within hours of birth of <2500 chiliad. Very low birth weight (VLBW) is accepted as <1500 1000 and extremely low birth weight (ELBW) is <k one thousand [1].
Within the definition context, however, the iii diagnostic levels must not be misunderstood as reflecting different grades of clinical severity. They instead reflect diagnostic certainty.
The levels of certainty accept been formulated such that the Level 1 definition is highly specific for the condition. Two additional diagnostic levels have been included in the definition, offering a stepwise loss of precision and accurateness from Level One downwardly to Level Three, while retaining an approach to expand utilization of available data. In this manner it is hoped that information on low nascence weight tin can be captured more than broadly at the population level.
one.iii.2. Timing of birth weight assessment
The nativity weight is described as the first weight measured, all the same, in settings with low rates of facility-based deliveries, a newborn may not exist assessed by a health intendance worker until several days old. Birth weight should be assessed within hours of birth, prior to pregnant weight loss [37]. Term neonates lose between 3.5% and 6.vi% of their birth weight within the start 2.5–2.7 days of life. Exclusively breastfed neonates take a greater weight loss (Median half dozen.6%, 95%CI six.3–half-dozen.9%) than formula-fed (Median 3.5%, 95%CI 3.0–3.nine%) or mixed fed (v.nine%, 95%CI 4.8–6.9%) neonates respectively, and have longer to regain their nascency weight (8.three vs. 6.v vs. 7.nine days) [37].
The LBW working group decided to restrict 'birth weight' to a weight measured in the first 48 h of life. In the absence of a weight measured within the showtime 48 h of life, a weight measured during the first week of life, could exist classified as an 'early neonatal weight' but not 'nativity weight'.
In a clinical trial scenario, measurement of weight within first 48 h of life should be achievable, as the clinical trial would procure adequate equipment, employ and train staff to appraise nascency weight in a timely manner, and enroll participants who reside in areas which are relatively easily accessed by trial or health care staff.
Many newborns globally are not weighed inside hours of birth, mainly due to difficulty in accessing health intendance personnel, facilities, and essential equipment. Specific time frames for onset of symptoms post-obit immunization are non included for the following main reasons:
We postulate that a definition designed to exist a suitable tool for testing causal relationships requires ascertainment of the upshot (east.g. low nativity weight) independent from the exposure (e.g. immunizations). Therefore, to avoid pick bias, a restrictive fourth dimension interval from immunization to nascence of a LBW newborn should non be an integral part of such a definition. Instead, where feasible, details of this interval should be assessed and reported as described in the data collection guidelines.
Farther, measurement of nascency weight often occurs outside the controlled setting of a clinical trial or hospital. In some settings information technology may exist incommunicable to obtain a clear timeline of the assessment of a birth weight, especially in less developed or rural settings. In gild to avert selecting against such cases, the Brighton Collaboration case definition avoids setting arbitrary time frames. The time betwixt delivery and measurement of birth weight should be recorded and deemed for in the analysis.
1.four. Guidelines for data collection, analysis and presentation
As mentioned in the overview paper [38], the case definition is accompanied by guidelines which are structured co-ordinate to the steps of conducting a clinical trial, i.e. information collection, analysis and presentation. Neither case definition nor guidelines are intended to guide or found criteria for management of ill infants, children, or adults. Both were adult to improve standardization of case definitions and information comparability.
1.5. Periodic review
Like to all Brighton Collaboration case definitions and guidelines, review of the definition with its guidelines is planned on a regular basis (i.east. every three to 5 years) or more ofttimes if needed.
2. Case definition of depression nascence weight3
Level 1 of diagnostic certainty
| Newborn baby weighed within 24 h of nativity | AND |
| Utilize electronic scale which is graduated to 10 g | AND |
| Scale is calibrated at least once a year | AND |
| Scale placed on level, hard surface | AND |
| Calibration tared to nix grams | AND |
| Weight recorded as <2500 one thousand | OR |
| Nascency weight recorded every bit <2500 1000 | AND |
| Birth weight assessed as per health care facility'due south standard operating process, which fulfills criteria 1 to five of LOC1 |
Level 2 of diagnostic certainty
| Newborn infant weighed within 24 h of nascency | AND |
| Scale (electronic/bound) is graduated to at to the lowest degree l g | AND |
| Scale is calibrated at least one time a year, or more than often if moved | AND |
| Scale tared to zero grams or 0.00 kg | AND |
| Weight recorded every bit <2500 thousand | OR |
| Birth weight recorded as <2500 one thousand | AND |
| Nascence weight assessed as per health care facility's standard operating process, which fulfills criteria 1 to 4 of LOC2 |
Scale used: could be electronic or bound scale, including color-coded scale.
Level 3 of diagnostic certainty
| Newborn babe weighed on twenty-four hour period i or 2 of life (commencement 48 h of life) | AND |
| Weight measured using dial/spring/color-coded calibration | AND |
| Weight assessed as <2500 g |
Level 4 of diagnostic certainty
| Newborn infant 'weight' assessed on day 1 or ii of life (first 48 h of life) | AND |
| Proxy measure of birth weight used | AND |
| Weight CATEGORY assessed as <2500 1000 |
In many settings, including high-income countries, nascency weight is assessed by a health care provider who is bellboy during/soon after commitment, and not the vaccine trialist/researcher. The details of fourth dimension of birth weight assessment, and details of calibration used and calibration details are usually not recorded in newborn assessment medical notes.
The newborn weight assessment is presumed to be assessed accurately equally per health care center'south standard operating procedures. In many instances, trialists need to rely on the attending medical staff at health intendance facility for nascency weight assessment. Strengthening preparation and oversight of birth weight measurement would exist expected to strengthen data both in clinical trials and post-marketing surveillance.
2.1. Other tools under investigation to approximate nascence weight in individuals and populations
Upwardly to 60 meg infants are born at domicile annually [39], and up to 48% of infants worldwide are not weighed at nascency [3]. Lack of access to wellness intendance facilities or health intendance workers hampers accurate assessment of low nascence weight rates in many regions. In order to identify small newborns, who could be preterm, IUGR, or both, who require additional care, cheap tools are required which can be utilized in the field.
The lack of data available has encouraged the evolution of a mathematical model to calculate the expected number of agin events, including neonatal and maternal deaths, SGA, preterm birth and major built malformations [40].
Several anthropometric measurements, including breast circumference, foot length and mid-upper arm circumference, have been assessed as proxies for birth weight [41], [42], [43], [44]. Table 1 summarizes these tools and their validity for identifying low nascence weight newborns. These tools at this point are considered investigational and have been included in level four definition just, which indicates that testify is inadequate to see the definition, however, may be useful for population background LBW estimates.
Table 1
Validated tools used as proxy measures of nativity weight.
| Measurement | Method of cess | Cut-off values used | Comments | |
|---|---|---|---|---|
| Newborn foot length [41], [42], [43], [46] | Pes length from center of heel pad to tip of large toe in millimeters | Hard plastic ruler pressed vertically against sole of foot (highest AUC) | 7.2 cm for 2000 g | Weakest correlation with LBW of all anthropometric measurements [47], [48] |
| Sole of foot placed on solid board with measuring tape | 7.8 cm for preterm [41] | |||
| ⩽7.iv cm (7.3–7.4 cm) for 2500 chiliad [43] | AUC 0.94, 95%CI 0.92–0.96 [43] | |||
| For <2500 g | ||||
| Footprint made on White paper, and tip of large toe and heel marked with pencil | 7.2 cm (Europe) | <8 cm at birth was 87% sensitive for LBW [46] | ||
| 6.3–7.85 cm (Asia) | ||||
| 7.iv–8 cm (Africa) | ||||
| Chest circumference [42], [43] | Chest circumference at level of nipples in centimeters | Non-elastic, flexible measuring tape graduated to nearest 0.1 cm, measured during expiration | ⩽thirty.4 cm (30.0–30.4 cm) [43] | Highly predictive of LBW if measured at <24 h of age (AUC 0.98, 95%CI 0.96–0.99) [43] |
| In meta-analysis, best anthropometric measurement to predict LBW [47] | ||||
| Take a chance of hypothermia | ||||
| Mid upper arm circumference [43] | Mid-point between tip of acromion procedure and olecranon procedure in centimeters | Non-elastic, flexible measuring record graduated to nearest 0.one cm | ⩽9.0 cm (8.7–nine.0 cm) [43] | Highly predictive of LBW if measured at <24 h of age (AUC 0.98, 95%CI 0.96–0.99) [43] |
In addition to these measurements, other tools are utilized in some communities to appraise birth weight, including difference between adult weight with and without newborn in arms (see Fig. 1).
Tools used to mensurate birth weight (See in a higher place-mentioned references for farther information.).
3. Guidelines for data collection, assay and presentation of low birth weight
It was the consensus of the Brighton Collaboration Working Grouping for Low nativity weight to recommend the following guidelines to enable meaningful and standardized drove, assay, and presentation of information about depression birth weight. However, implementation of all guidelines might not be possible in all settings. The availability and quality of information may vary depending upon resources, geographical region, and whether the source of information is a prospective clinical trial, epidemiological written report, post-marketing surveillance, or an individual report. Also, as explained in more particular in the overview paper [38], these guidelines have been adult past this working group for guidance simply, and are non to be considered a mandatory requirement for information collection, analysis, or presentation.
3.1. Data collection
These guidelines represent a desirable standard for the collection of data on availability following immunization to permit for comparability of information, and are recommended as an improver to information collected for the specific written report question and setting. The guidelines are non intended to guide the primary reporting of low nativity weight to a surveillance system or study monitor. Investigators developing a data collection tool based on these data collection guidelines besides need to refer to the criteria in the example definition, which are not repeated in these guidelines.
Guidelines numbers below have been developed to address data elements for the collection of agin outcome information as specified in general drug safety guidelines by the International Briefing on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Employ [49], and the form for reporting of drug adverse events by the Council for International Organizations of Medical Sciences [50]. These data elements include an identifiable reporter and patient, one or more prior immunizations, and a detailed description of the adverse event, in this case, of low birth weight following immunization. The boosted guidelines have been developed as guidance for the collection of boosted information to allow for a more comprehensive understanding of low nascence weight following maternal immunization.
3.one.1. Source of information/reporter
For all cases and/or all report participants, every bit appropriate, the following data should be recorded:
-
(1)
Engagement of study.
-
(2)
Proper noun and contact information of person reporting4 and/or diagnosing low birth weight as specified past land-specific data protection law.
-
(3)
Proper name and contact information of the investigator responsible for the subject, as applicable.
-
(4)
Relation to the patient (e.g., healthcare provider, immunizer, community health worker, family member [point relationship], other).
iii.1.two. Vaccinee/control
3.1.2.1. Demographics
For all cases and/or all written report participants, as appropriate, the following data should be recorded:
-
(v)
Case/study participant identifiers for mother and newborn (eastward.m. first name initial followed by last name initial) or code (i.due east. hospital identifier or in accordance with country-specific data protection laws). Each newborn should have a unique identifier, ideally linked to female parent's identifier (e.g. participant code could be aforementioned for female parent and baby(ies), with an added prefix/suffix to identify mother/infant).
-
(6)
Maternal date of nascence, or if not available, maternal historic period.
-
(7)
For each babe: Date and time of delivery, unmarried or multiple, alive nativity vs. fetal decease (fresh or diminished), estimated gestational historic period, method of determination of gestational historic period (LMP, fundal height, beginning trimester ultrasound) and birth weight.
- • For collection of birth weight, ideally tape timeline of weight measurement (e.grand. time of delivery to time of weight), type of scale used (e.g. surface-mounted jump) and identify where nascence weight was measured (due east.g. wellness care facility, mobile health worker visiting domicile).
3.1.2.2. Clinical and immunization history
For all cases and/or all study participants, as appropriate, the post-obit information should be recorded:
-
(viii)
Maternal by medical history, including hospitalizations, gravidity and parity, underlying diseases/disorders; complications of pregnancy, labor, or delivery; pre-immunization signs and symptoms including identification of indicators for, or the absence of, a history of allergy to vaccines, vaccine components or medications; food allergy; allergic rhinitis; eczema; asthma.
-
(nine)
Whatsoever medication history (other than treatment for the event described) prior to, during, and after immunization including prescription and non-prescription medication also as medication or treatment with long half-life or long term result. (E.m. immunoglobulins, claret transfusion and immunosuppressants).
-
(10)
Immunization history (i.e. previous immunizations and any adverse upshot following immunization (AEFI)), in particular occurrence of low nascency weight later a previous maternal immunization.
3.1.3. Details of the immunization
For all cases and/or all study participants, equally appropriate, the post-obit information should be recorded:
-
(11)
Engagement and time of maternal immunization(s).
-
(12)
Clarification of vaccine(south) (name of vaccine, manufacturer, lot number, dose (eastward.g. 0.25 mL, 0.v mL), vaccine diluent (limerick and lot number) and number of dose if function of a serial of immunizations confronting the same disease).
-
(thirteen)
The anatomical sites (including left or right side) of all immunizations (e.thou. vaccine A in proximal left lateral thigh, vaccine B in left deltoid).
-
(14)
Route and method of assistants (e.chiliad. intramuscular, intradermal, subcutaneous, and needle-complimentary (including type and size), other injection devices).
-
(15)
Needle length and gauge.
3.1.4. The adverse event
-
(16)
For all cases at whatsoever level of diagnostic certainty and for reported events with insufficient evidence, the criteria fulfilled to meet the example definition should be recorded.
Specifically document:
-
(17)
Severity of Low nascency weight (LBW, VLBW or ELBW), and if there was medical confirmation of the LBW (i.e. patient seen by physician/other health care worker).
-
(18)
Engagement/time of ascertainment,5 and diagnosis.half dozen
-
(19)
Concurrent signs, symptoms, and diseases, including prematurity.
-
(20)
Measurement/testing.
- • Values and units of routinely measured parameters (grams for birth weight);
- • Method of measurement (due east.g. type of scale.);
- • Weight should be recorded with minimal or ideally no clothing;
-
(21)
Objective clinical evidence supporting classification of the result as "serious".7
-
(22)
Exposures other than the immunization 24 h before and after immunization (east.thou. infection, ecology) considered potentially relevant to the reported effect.8
3.i.5. Miscellaneous/general
-
(23)
The elapsing of surveillance for low nascence weight should be from 0 to 48 h of life. Any weight measured after 48 h of historic period should not exist considered a 'nascence weight'.9
-
(24)
Methods of information collection should be consequent inside and between written report groups, if applicable.ten
-
(25)
Investigators of patients with depression birth weight should provide guidance to reporters to optimize the quality and completeness of information provided.
3.two. Data analysis
The post-obit guidelines represent a desirable standard for analysis of data on low birth weight to let for comparability of data, and are recommended every bit an addition to data analyzed for the specific study question and setting.
-
(26)
Reported events should be classified in ane of the following v categories including the three levels of diagnostic certainty. Events that meet the instance definition should be classified according to the levels of diagnostic certainty every bit specified in the case definition. Events that practise not run across the case definition should be classified in the additional categories for analysis.
Event classification in five categories
Event meets example definition
-
(1)
Level 1: Criteria as specified in the Depression nascency weight example definition
-
(two)
Level 2: Criteria every bit specified in the Low nascence weight instance definition
-
(3)
Level 3: Criteria as specified in the Low nascency weight case definition
Effect does not come across example definition
Boosted categories for analysis
-
(4)
Reported Depression birth weight with insufficient evidence to run across the case definition.7
-
(5)
Birth weight not assessed, therefore data unavailable.
-
(27)
The interval between immunization and reported Low birth weight could be defined as the date/time of immunization to the date/time of cess4 of nascence weight. If few cases are reported, the concrete time grade could exist analyzed for each; for a large number of cases, data tin be analyzed in the following increments.
-
(28)
If birth weight is assessed past more than than one method, the value recorded which fulfills the highest level of certainty should be used as the footing for analysis.
-
(29)
The distribution of birth weight data could be analyzed in predefined increments (e.g. LBW < 2500 g, VLBW < 1500 g, ELBW < 1000 yard). Increments specified above should be used. When only a small number of cases are presented, the respective values can be presented individually.
-
(30)
Data on Low nascence weight obtained from participants whose mothers received a vaccine should be compared with those obtained from an accordingly selected and documented control group to assess background rates of LBW in not-exposed populations, and should be analyzed past study arm and dose where possible, due east.thousand. in prospective clinical trials.
three.iii. Data presentation
These guidelines represent a desirable standard for the presentation and publication of information on Low birth weight post-obit immunization to let for comparability of data, and are recommended as an add-on to data presented for the specific written report question and setting. Additionally, it is recommended to refer to existing full general guidelines for the presentation and publication of randomized controlled trials, systematic reviews, and meta-analyses of observational studies in epidemiology (e.grand. statements of Consolidated Standards of Reporting Trials (Espoused) [51], of Improving the quality of reports of meta-analyses of randomized controlled trials (QUORUM) [52], and of meta-analysis Of Observational Studies in Epidemiology (MOOSE) [53], respectively).
-
(31)
All reported events of Low birth weight should be presented according to the categories listed in guideline 31.
-
(32)
Data on Depression birth weight events should be presented in accordance with data drove guidelines one–25 and data analysis guidelines 26–thirty.
-
(33)
Data should be presented as rates with a numerator and denominator (n/N) (and not just in percentages), with confidence intervals around the point estimates.
Although immunization safety surveillance systems denominator information are ordinarily non readily bachelor, attempts should be made to place gauge denominators. The source of the denominator information should be reported and calculations of estimates be described (e.g. manufacturer data like total doses distributed, reporting through Ministry of Health, coverage/population based data, etc.).
-
(34)
The incidence of cases in the study population should be presented and clearly identified equally such in the text.
-
(35)
If the distribution of birth weight data is skewed, median and range are normally the more appropriate statistical descriptors than a mean. Still, the mean and standard deviation should too exist provided.
-
(36)
Any publication of data on Low birth weight should include a detailed description of the methods used for data drove and analysis as possible. It is essential to specify:
- • The study design;
- • The method, frequency and duration of monitoring for Low nascency weight;
- • The trial contour, indicating participant flow during a written report including drop-outs and withdrawals to betoken the size and nature of the corresponding groups nether investigation;
- • The type of surveillance (eastward.g. passive or active surveillance);
- • The characteristics of the surveillance system (e.grand. population served, way of written report solicitation);
- • The search strategy in surveillance databases;
- • Comparison grouping(s), if used for analysis;
- • The instrument of information drove (due east.chiliad. standardized questionnaire, diary card, report form);
- • Whether the solar day of immunization was considered "solar day i" or "day nix" in the analysis;
- • Whether the appointment of onset4 and/or the engagement of beginning observation5 and/or the date of diagnosis6 was used for analysis; and
- • Utilize of this instance definition for Low nascency weight, in the abstract or methods section of a publication.11
Disclaimer
The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant's organisation (e.g., authorities, academy, or corporation). Specifically, the findings and conclusions in this newspaper are those of the authors and do non necessarily represent the views of their respective institutions.
Acknowledgements
The authors are grateful for the back up and helpful comments provided by the Brighton Collaboration Steering Commission and Reference group, as well equally other experts consulted equally part of the procedure. The authors would like to thank the following working group members for their contribution: Trésor Bodjick, Brian Magowan, Jeffrey Murray. The authors are grateful to Karalee Sheaffer of the Scientific Intelligence group at Sanofi Pasteur for the "pregnancy, vaccines and depression birth weight" literature search. The authors are as well grateful to Jan Bonhoeffer, Jorgen Bauwens of the Brighton Collaboration Secretariat and Sonali Kochhar of Global Healthcare Consulting for concluding revisions of the concluding document.
Footnotes
3The example definition should be applied when at that place is no clear alternative diagnosis for the reported event to account for the combination of symptoms.
4If the reporting center is unlike from the vaccinating middle, advisable and timely communication of the agin outcome should occur.
5The date and/or fourth dimension of observation is defined as the time post immunization, when the Low birth weight was recorded.
6The date of diagnosis of an episode is the day post immunization when the event met the case definition at any level.
7An AEFI is defined as serious by international standards if it meets one or more of the following criteria: (i) it results in death, (2) is life-threatening, (3) it requires inpatient hospitalization or results in prolongation of existing hospitalization, (4) results in persistent or significant disability/incapacity, (v) is a built anomaly/birth defect, (vi) is a medically of import event or reaction.
8To decide the appropriate category, the user should start institute, whether a reported event meets the criteria for the lowest applicative level of diagnostic certainty, e.g. Level three. If the lowest applicable level of diagnostic certainty of the definition is met, and there is evidence that the criteria of the next college level of diagnostic certainty are met, the event should be classified in the next category. This approach should be continued until the highest level of diagnostic certainty for a given outcome could be determined. Major criteria can be used to satisfy the requirement of modest criteria. If the lowest level of the case definition is not met, it should exist ruled out that any of the higher levels of diagnostic certainty are met and the result should be classified in additional categories 4 or five.
nineIf the evidence available for an event is bereft because information is missing, such an event should exist categorized equally "Reported Low birth weight with insufficient evidence to run into the case definition".
10An event does not meet the case definition if investigation reveals a negative finding of a necessary criterion (necessary status) for diagnosis. Such an event should be rejected and classified every bit "Not a case of Low nascence weight".
11Utilise of this certificate should preferably exist referenced by referring to the respective link on the Brighton Collaboration website (http://www.brightoncollaboration.org).
Appendix ASupplementary information associated with this article can be found, in the online version, at https://doi.org/ten.1016/j.vaccine.2017.01.049.
Appendix A. Supplementary cloth
References
1. System WH. International statistical classification of diseases and related health problems, tenth revision, second ed. World Health Organization; 2004.
2. Quinn J.A., Munoz F.Thousand., Gonik B., Frau L., Cutland C., Mallet-Moore T., Kissou A., Wittke F., Das M., Nunes T., Pye S., Watson W., Ramos A.A., Cordero J.F., Huang Due west.T., Kochhar S., Buttery J., Brighton Collaboration Preterm Birth Working Group Preterm birth: Instance definition & guidelines for data drove, analysis, and presentation of immunisation condom data. Vaccine. 2016;34(49):6047–6056. [PMC free article] [PubMed] [Google Scholar]
3. WHO. Global nutrition targets 2025: depression birth weight policy brief Geneva. Earth Health Organization; 2014.
4. Lawn J.E., Cousens S., Zupan J. 4 one thousand thousand neonatal deaths: when? Where? Why? Lancet. 2005;365(9462):891–900. [PubMed] [Google Scholar]
5. Johnson C.D., Jones S., Paranjothy S. Reducing depression nascency weight: prioritizing action to address modifiable take a chance factors. J Public Health (Oxf) 2016 [PMC gratis article] [PubMed] [Google Scholar]
vi. Islam G.M. Increasing incidence of infants with low birth weight in Oman. Sultan Qaboos Univ Med J. 2015;15(2):e177–e183. [PMC gratuitous commodity] [PubMed] [Google Scholar]
7. Arrangement UNCsFaWH. Low Birthweight. Country, regional and global estimates. UNICEF, New York: United Nations Children's Fund and World Health Organization; 2004.
8. Kramer M.S. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Wellness Organ. 1987;65(v):663–737. [PMC free article] [PubMed] [Google Scholar]
9. Badshah Southward., Stonemason 50., McKelvie Yard., Payne R., Lisboa P.J. Take a chance factors for depression birthweight in the public-hospitals at Peshawar, NWFP-Islamic republic of pakistan. BMC Pub Health. 2008;8:197. [PMC free article] [PubMed] [Google Scholar]
10. Zerbeto A.B., Cortelo F.K., Élio Filho B.C. Association between gestational historic period and birth weight on the language evolution of Brazilian children: a systematic review. J de Pediatr. 2015;91(4):326–332. [PubMed] [Google Scholar]
11. You D., Hug 50., Ejdemyr S., Idele P., Hogan D., Mathers C. Global, regional, and national levels and trends in under-v mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the Un Inter-agency Group for Kid Mortality Estimation. Lancet. 2015;386(10010):2275–2286. [PubMed] [Google Scholar]
12. Sicuri Eastward., Bardaji A., Sigauque B., Maixenchs G., Nhacolo A., Nhalungo D. Costs associated with depression birth weight in a rural area of Southern Mozambique. PLoS 1. 2011;6(12):e28744. [PMC free article] [PubMed] [Google Scholar]
13. Villar J., Papageorghiou A.T., Knight H.East., Gravett M.G., Iams J., Waller S.A. The preterm birth syndrome: a prototype phenotypic classification. Am J Obstet Gynecol. 2012;206(2):119–123. [PubMed] [Google Scholar]
14. Goldenberg R.L., Gravett M.G., Iams J., Papageorghiou A.T., Waller S.A., Kramer M. The preterm nascence syndrome: issues to consider in creating a classification system. Am J Obstet Gynecol. 2012;206(2):113–118. [PubMed] [Google Scholar]
15. Sharma D., Shastri S., Sharma P. Intrauterine growth restriction: antenatal and postnatal aspects. Clin Med Insights Pediatr. 2016;ten:67–83. [PMC free commodity] [PubMed] [Google Scholar]
xvi. Goldenberg R.L., Culhane J.F., Iams J.D., Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371(9606):75–84. [PMC free article] [PubMed] [Google Scholar]
17. Bhaskar R.Yard., Deo G.Chiliad., Neupane U., Chaudhary Bhaskar South., Yadav B.One thousand., Pokharel H.P. A case control study on chance factors associated with low birth weight babies in Eastern Nepal. Int J Pediatr. 2015;2015:807373. [PMC free article] [PubMed] [Google Scholar]
eighteen. Romero R., Espinoza J., Goncalves L.F., Kusanovic J.P., Friel Fifty., Hassan S. The role of inflammation and infection in preterm birth. Semin Reprod Med. 2007;25(1):21–39. [PMC complimentary article] [PubMed] [Google Scholar]
xix. Romero R., Dey S.One thousand., Fisher South.J. Preterm labor: one syndrome, many causes. Scientific discipline. 2014;345(6198):760–765. [PMC costless article] [PubMed] [Google Scholar]
20. de Moraes-Pinto M.I., Verhoeff F., Chimsuku L., Milligan P.J., Wesumperuma L., Broadhead R.L. Placental antibiotic transfer: influence of maternal HIV infection and placental malaria. Arch Dis Kid Fetal Neonatal Ed. 1998;79(3):F202–F205. [PMC free commodity] [PubMed] [Google Scholar]
21. Saunders 1000. Transplacental transport of nanomaterials. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2009;one(6):671–684. [PubMed] [Google Scholar]
22. van den Berg J.P., Westerbeek E.A., van der Klis F.R., Berbers G.A., van Elburg R.M. Transplacental transport of IgG antibodies to preterm infants: a review of the literature. Early Hum Dev. 2011;87(two):67–72. [PubMed] [Google Scholar]
23. Okoko B.J., Wesumperuma L.H., Hart A.C. Materno-foetal transfer of H. influenzae and pneumococcal antibodies is influenced past prematurity and low birth weight: implications for conjugate vaccine trials. Vaccine. 2001;20(5–6):647–650. [PubMed] [Google Scholar]
24. Scott S., Cumberland P., Shulman C.Due east., Cousens S., Cohen B.J., Chocolate-brown D.West. Neonatal measles immunity in rural Kenya: the influence of HIV and placental malaria infections on placental transfer of antibodies and levels of antibody in maternal and cord serum samples. J Infect Dis. 2005;191(11):1854–1860. [PubMed] [Google Scholar]
25. Moro L., Bardaji A., Nhampossa T., Mandomando I., Serra-Casas Eastward., Sigauque B. Malaria and HIV infection in Mozambican pregnant women are associated with reduced transfer of antimalarial antibodies to their newborns. J Infect Dis. 2015;211(6):1004–1014. [PubMed] [Google Scholar]
26. Bardaji A., Steinhoff M., Macete East., Aguado T., Menendez C. The burden of vaccine-preventable diseases in pregnancy in low-resource settings. Lancet Glob Health. 2016;4(3):e152–e153. [PubMed] [Google Scholar]
27. Cumberland P., Shulman C.East., Maple P.A., Bulmer J.N., Dorman E.Thou., Kawuondo K. Maternal HIV infection and placental malaria reduce transplacental antibiotic transfer and tetanus antibody levels in newborns in Republic of kenya. J Infect Dis. 2007;196(4):550–557. [PubMed] [Google Scholar]
28. Farquhar C., Nduati R., Haigwood N., Sutton West., Mbori-Ngacha D., Richardson B. Loftier maternal HIV-1 viral load during pregnancy is associated with reduced placental transfer of measles IgG antibody. J Acquir Allowed Defic Syndr. 2005;40(4):494–497. [PMC gratis article] [PubMed] [Google Scholar]
29. Brair One thousand.Due east., Brabin B.J., Milligan P., Maxwell South., Hart C.A. Reduced transfer of tetanus antibodies with placental malaria. Lancet. 1994;343(8891):208–209. [PubMed] [Google Scholar]
30. Owens S., Harper Thou., Amuasi J., Offei-Larbi G., Ordi J., Brabin B.J. Placental malaria and immunity to infant measles. Curvation Dis Child. 2006;91(6):507–508. [PMC free commodity] [PubMed] [Google Scholar]
31. Okoko B.J., Wesuperuma L.H., Ota M.O., Banya W.A., Pinder M., Gomez F.Southward. Influence of placental malaria infection and maternal hypergammaglobulinaemia on materno-foetal transfer of measles and tetanus antibodies in a rural west African population. J Health Popul Nutr. 2001;xix(2):59–65. [PubMed] [Google Scholar]
32. Chucri T.K., Monteiro J.Thou., Lima A.R., Salvadori K.50., Kfoury J.R., Jr., Miglino K.A. A review of allowed transfer by the placenta. J Reprod Immunol. 2010;87(ane–two):14–20. [PubMed] [Google Scholar]
33. Jones C.E., Naidoo S., De Beer C., Esser Thou., Kampmann B., Hesseling A.C. Maternal HIV infection and antibody responses against vaccine-preventable diseases in uninfected infants. JAMA. 2011;305(6):576–584. [PubMed] [Google Scholar]
34. Rasmussen Southward.A., Jamieson D.J., Uyeki T.K. Effects of flu on significant women and infants. Am J Obstet Gynecol. 2012;207(three Suppl):S3–S8. [PubMed] [Google Scholar]
35. Steinhoff Chiliad.C., Omer Due south.B., Roy E., El Arifeen S., Raqib R., Dodd C. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ. 2012;184(6):645–653. [PMC free article] [PubMed] [Google Scholar]
36. Madhi South.A., Nunes M.C., Cutland C.L. Influenza vaccination of pregnant women and protection of their infants. N Engl J Med. 2014;371(24):2340. [PubMed] [Google Scholar]
37. Macdonald P.D., Ross S.R., Grant Fifty., Young D. Neonatal weight loss in breast and formula fed infants. Arch Dis Child Fetal Neonatal Ed. 2003;88(6):F472–F476. [PMC gratis commodity] [PubMed] [Google Scholar]
38. Jones C.E., Munoz F.M., Spiegel H.Thousand., Heininger U., Zuber P.50., Edwards K.M. Guideline for collection, analysis and presentation of safety information in clinical trials of vaccines in pregnant women. Vaccine. 2016 [PMC free article] [PubMed] [Google Scholar]
39. UNICEF. The State of the World's Children 2009. Maternal and Newborn Health; 2008.
twoscore. Orenstein L.A., Orenstein Due east.W., Teguete I., Kodio Grand., Tapia Yard., Sow Southward.O. Background rates of adverse pregnancy outcomes for assessing the safe of maternal vaccine trials in sub-Saharan Africa. PLoS I. 2012;7(10):e46638. [PMC gratis article] [PubMed] [Google Scholar]
41. Kc A., Nelin Five., Vitrakoti R., Aryal South., Malqvist M. Validation of the pes length measure out as an alternative tool to identify low birth weight and preterm babies in a low-resource setting similar Nepal: a cross-sectional study. BMC Pediatr. 2015;15:43. [PMC costless commodity] [PubMed] [Google Scholar]
42. Mullany L.C., Darmstadt 1000.L., Khatry Due south.K., Leclerq S.C., Tielsch J.1000. Relationship betwixt the surrogate anthropometric measures, foot length and chest circumference and birth weight among newborns of Sarlahi, Nepal. Eur J Clin Nutr. 2007;61(i):twoscore–46. [PMC gratuitous commodity] [PubMed] [Google Scholar]
43. Thi H.N., Khanh D.K., Thu Hle T., Thomas E.Thou., Lee Grand.J., Russell F.Thou. Pes length, chest circumference, and mid upper arm circumference are proficient predictors of low birth weight and prematurity in indigenous minority newborns in Vietnam: a infirmary-based observational written report. PLoS ONE. 2015;10(11):e0142420. [PMC free commodity] [PubMed] [Google Scholar]
44. Nabiwemba E.L., Atuyambe L., Criel B., Kolsteren P., Orach C.G. Recognition and home care of depression birth weight neonates: a qualitative study of noesis, beliefs and practices of mothers in Iganga-Mayuge Wellness and Demographic Surveillance Site, Uganda. BMC Pub Wellness. 2014;xiv:546. [PMC free article] [PubMed] [Google Scholar]
45. Mullany L.C., Darmstadt G.L., Coffey P., Khatry Due south.Chiliad., LeClerq S.C., Tielsch J.M. A depression price, colour coded, paw held spring scale accurately categorises birth weight in low resource settings. Curvation Dis Child. 2006;91(5):410–413. [PMC free commodity] [PubMed] [Google Scholar]
46. Marchant T., Jaribu J., Penfold S., Tanner 1000., Armstrong Schellenberg J. Measuring newborn pes length to place pocket-size babies in demand of extra care: a cantankerous sectional hospital based report with customs follow-upwardly in Tanzania. BMC Publ Wellness. 2010;10:624. [PMC free article] [PubMed] [Google Scholar]
47. Goto E. Meta-analysis: identification of depression birthweight by other anthropometric measurements at birth in developing countries. J Epidemiol. 2011;21(five):354–362. [PMC free article] [PubMed] [Google Scholar]
48. Otupiri E., Wobil P., Nguah South.B., Hindin Thou.J. Anthropometric measurements: options for identifying depression birth weight newborns in Kumasi, Ghana. PLoS One. 2014;9(9):e106712. [PMC complimentary article] [PubMed] [Google Scholar]
49. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised TripartiteGuideline safety pharmacology studies for homo pharmaceuticals S7A Cur-rent Step 4 version; 2000.
50. CIOMS. Reporting agin drug reactions: definitions of terms and criteria for their use. South Med J 2000;102(four):345.
51. Schulz K.F., Altman D.G., Moher D., Group C. Espoused 2010 argument: updated guidelines for reporting parallel grouping randomised trials. PLoS Med. 2010;7(iii):e1000251. [PMC free article] [PubMed] [Google Scholar]
52. Moher D., Cook D.J., Eastwood Southward., Olkin I., Rennie D., Stroup D.F. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta-analyses. Lancet. 1999;354(9193):1896–1900. [PubMed] [Google Scholar]
53. Stroup D.F., Berlin J.A., Morton S.C., Olkin I., Williamson M.D., Rennie D. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA. 2000;283(fifteen):2008–2012. [PubMed] [Google Scholar]
tarantinovoiceselen.blogspot.com
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710991/
0 Response to "A Low-birthweight Baby Is Defined as One Who Weighs Less Than 5 1/2 Pounds."
Post a Comment