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What Legal Substance Accounts for 20% to 30% of Pre-term Babies and 10% of Infant Deaths?

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Vaccine. 2017 Dec 4; 35(48Part A): 6492–6500.

Depression birth weight: Case definition & guidelines for information collection, assay, and presentation of maternal immunization condom data

Clare 50. Cutland,a, b, c, ⁎ Eve M. Lackritz,d Tamala Mallett-Moore,due east Azucena Bardají,f Ravichandran Chandrasekaran,g Chandrakant Lahariya,h Muhammed Imran Nisar,i Milagritos D. Tapia,j Jayani Pathirana,a, b, c Sonali Kochhar,k, m, 1 Flor M. Muñoz,l and The Brighton Collaboration Low Nativity Weight Working Group2

Clare L. Cutland

aMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa

bDepartment of Science and Technology National Inquiry Foundation, Vaccine Preventable Diseases, S Africa

cFaculty of Wellness Sciences, Academy of the Witwatersrand, Johannesburg, Due south Africa

Eve G. Lackritz

dGlobal Alliance to Prevent Prematurity and Stillbirth (GAPPS), Seattle Children'south Research Constitute, Seattle, WA, Us

Tamala Mallett-Moore

eSanofi Pasteur Inc., Swiftwater, PA, The states

Azucena Bardají

fISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Infirmary Clínic – University of Barcelona, Barcelona, Espana

Ravichandran Chandrasekaran

gMadras Medical College, India

Chandrakant Lahariya

hDepartment of Community Medicine, GR Medical College and Associated Hospitals, Gwalior, MP, Republic of india

Muhammed Imran Nisar

iSection of Pediatrics and Child Health, Aga Khan Academy, Karachi, Pakistan

Milagritos D. Tapia

jUniversity of Maryland Schoolhouse of Medicine, Center for Vaccine Evolution, MD, United states

Jayani Pathirana

aMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa

bDepartment of Scientific discipline and Applied science National Inquiry Foundation, Vaccine Preventable Diseases, Due south Africa

cFaculty of Health Sciences, Academy of the Witwatersrand, Johannesburg, South Africa

Sonali Kochhar

kGlobal Healthcare Consulting, Bharat

mErasmus University Medical Eye, Rotterdam, The Netherlands

Flor G. Muñoz

lBaylor Higher of Medicine, Departments of Pediatrics, Molecular Virology and Microbiology, Houston, TX, Usa

Keywords: Depression birth weight, Adverse event, Immunization, Guidelines, Instance definition

one. Preamble

one.1. Demand for developing instance definitions and guidelines for data collection, analysis, and presentation for depression birth weight as an agin event following maternal immunization

The birth weight of an infant is the showtime weight recorded after birth, ideally measured inside the first hours afterwards nascence, before significant postnatal weight loss has occurred. Low birth weight (LBW) is defined every bit a birth weight of less than 2500 yard (up to and including 2499 one thousand), as per the World Health Organization (WHO) [ane]. This definition of LBW has been in beingness for many decades. In 1976, the 29th Globe Health Assembly agreed on the currently used definition. Prior to this, the definition of LBW was '2500 g or less'. Depression birth weight is further categorized into very low birth weight (VLBW, <1500 g) and extremely low nascence weight (ELBW, <thousand m) [ane]. Depression nascence weight is a result of preterm nascence (PTB, short gestation <37 completed weeks), intrauterine growth restriction (IUGR, also known as fetal growth restriction), or both.

The term low birth weight refers to an absolute weight of <2500 1000 regardless of gestational historic period. Pocket-size for gestational age (SGA) refers to newborns whose birth weight is less than the 10th percentile for gestational age. This report volition focus specifically on birth weight <2500 yard. Further details related to case definitions for PTB [2], IUGR and SGA are included in divide GAIA reports.

Globally, it is estimated that 15–20% of all births, or >twenty million newborns annually, are low birth weight infants. Low- and middle-income countries account for a disproportionate brunt of LBW; over 95% of the earth's LBW infants are born in LMICs. There are marked global and regional variations in LBW rates. An estimated six% of infants are built-in LBW in East Asia and the Pacific, 13% in Sub-Saharan Africa, and upwards to 28% in Southern asia [3]. Up to half of all LBW infants are built-in in southern asia [4]. High-income regions report lower LBW rates, including half dozen.9% from UK [v]. Of business is the estimated increase in LBW rates in sure middle-income countries such every bit Oman, where the LBW rate went from iv% in 1980 to 8.1% in 2000 [6].

I 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 data oftentimes rely on modeled estimates, with statistical methods to arrange for underreporting and misreporting of birth weight. In the context of vaccine condom monitoring, authentic ascertainment of nativity weight in LMICs will continue to crave attention and investment to improve accuracy and reporting of this of import health indicator.

ane.i.1. Why are nosotros concerned well-nigh depression nascency weight?

Depression birth weight is a valuable public wellness indicator of maternal wellness, nutrition, healthcare delivery, and poverty. Neonates with low nativity weight have a >xx times greater gamble of dying than neonates with nativity weight of >2500 g [eight], [9]. Additionally, low birth weight is associated with long-term neurologic disability, impaired language development [10], impaired academic achievement, and increased run a risk of chronic diseases including cardiovascular disease and diabetes. Preterm infants carry boosted chance due to immaturity of multiple organ systems, including intracranial hemorrhage, respiratory distress, sepsis, blindness, and gastrointestinal disorders. Preterm nativity is the leading cause of all nether-5 kid mortality worldwide [11].

In addition, economic studies in depression-income settings accept demonstrated that reducing the burden of low birth weight would have of import toll savings both to the health organization and to households [12].

1.ane.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 atmospheric condition are quite unlike [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 [xiii]. Pregnant maternal conditions include actress-uterine infection, chorioamnionitis, trauma and illness (eastward.g. pre-eclampsia/eclampsia). Pregnant fetal conditions include IUGR, fetal infection, death and anomalies. Placental pathologic conditions include placental abruption and placenta praevia [13].

In general, the causes of IUGR can be due to maternal, fetal, and placental factors. Although the etiologies are dissimilar, they often accept the last common pathway of insufficient uterine-placental perfusion and fetal nutrition.

IUGR can be asymmetrical IUGR (where babies have features of malnutrition), symmetrical IUGR (hypoplastic pocket-sized for dates) or mixed IUGR. Asymmetrical IUGR is the most mutual (seventy–80%) form of IUGR, resulting from an insult (often utero-placental insufficiency) later on in pregnancy, which results in affected babies having normal length and head circumference (brain sparing), but reduced weight. Symmetrical IUGR on the other hand arises from an insult (frequently genetic, structural or infectious) occurring earlier in pregnancy leading to a reduction in all anthropometric parameters in fetus/newborn [15].

Insufficient perfusion, through aberrant placentation, aberrant placental vascularization, maternal hypertensive disorders, and tobacco use, all result in IUGR. Multiple gestation (i.e., twins, triplets) is associated with increased hazard of both IUGR and PTB [16]. Infectious diseases, including intrauterine infections, HIV, and malaria, result in LBW due to both growth restriction and brusk gestation. Multiple maternal characteristics, risk behaviors, and social determinants are associated with both IUGR and PTB; these include maternal curt stature, maternal malnutrition, low body mass index, poverty, black race, narrow child spacing, low maternal pedagogy, poor antenatal care, substance abuse, and emotional and physical stress [v], [17], [18], [xix]. How these factors are mediated biologically remains poorly understood.

Preterm nascency may be spontaneous or medically-indicated, such as induction or cesarean department for maternal complications such as pre-eclampsia. Infectious and inflammatory processes are associated with increased adventure for PTB, including chorioamnionitis, bacterial vaginosis, bacteriuria, and systemic or remote site infection such as sepsis and periodontal disease.

1.i.3. The importance of short gestation on immune role and vaccine efficacy

Transplacental antibody transfer is an agile procedure mediated past Fc receptors in the placental syncytiotrophoblast [xx], which increases from 30 weeks gestation. Small molecular weight particles (<600 Da) cross the placenta by passive machinery including diffusion, nonetheless, larger molecular weight particles (>m Da) are transported beyond 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 rapidly through the third trimester [22]. Preterm newborns have significantly lower antibody levels than term newborns [22]. LBW term newborns take significantly lower antibody concentrations to Canker simplex virus type one, respiratory syncytial virus ad varicella zoster virus than term newborns with birth weight >2500 g [23].

Maternal antibody levels, receptor density and functionality, ardor, antigen nature, and gestational age decide the efficiency of placental antibody transfer [24]. Diseases that are highly prevalent in some areas, such as malaria and human being immunodeficiency virus (HIV), are known to cause placental damage, peculiarly placental malaria [25], [26]. Maternal HIV infection has been consistently associated with reduced placental passage of antibodies confronting 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 antibody production in the fetus and provides short-term passive immunity [32], conditioning the success of vaccination in newborns [33] which is specially important in preterm and IUGR newborns. Multiple comorbidities are associated with both LBW and immune suppression, such equally malnutrition and infection, thereby further exacerbating diminished immune role in the compromised newborn.

1.1.four. Maternal immunization and birth weight

Maternal infections, including influenza, take been associated with increased gamble of depression birth weight newborns [34]. Equally a corollary, prevention of certain infections during pregnancy might take a protective effect against LBW. This has been observed in a maternal immunization trial conducted in Bangladesh [35], in which the mean nascence weight of infants built-in to mothers who received an inactivated influenza vaccine during pregnancy was college than of infants built-in to mothers who received a pneumococcal polysaccharide vaccine (3178 g vs. 2978 m, p = 0.02). This tendency has not been observed in other maternal influenza immunization trials [36].

The field of immunization of significant women has highlighted the importance of knowing background rates of agin pregnancy events, including LBW, PTB, SGA, IUGR, stillbirths, and neonatal death, which can vary markedly betwixt and within regions. The greatest bear upon of disease prevention from maternal immunization is expected to be observed in LMIC, where the brunt of affliction is greatest and access to health intendance services is most limited. For this reason, particular attention is being given to advancing maternal immunization trials in LMICs. Unfortunately, reliable, accurate, and timely reports of vital statistics and demographic information are ofttimes limited in these settings.

Data Condom Monitoring Boards are established to review clinical trial information, including regular cess or review of adverse outcome rates in trial participants. Without authentic information on background rates of depression birthweight and other adverse pregnancy outcomes, it volition be incommunicable to find an increase in adverse events following immunization. Evolution of standardized methods to collect and report LBW and other essential outcomes will be essential to advancing maternal immunization programs worldwide.

Birth weight is usually included under demographics of trial participant infants, and the differences in birth weights between participants enrolled in agile and placebo or command arms of interventional trials in pregnancy are ordinarily assessed.

The LBW Working Group recommends use of traditional case definitions of LBW as defined by the Earth Health Organisation. This study therefore focuses on delineating data quality related to methods used to judge birth weight in LMICs, and summarizes some surrogate measurements that are under investigation to assess birth weight and estimate population-level background LBW rates.

1.two. Methods for the review of the case definition and guidelines for data collection, analysis, and presentation for low birth weight in clinical trial and population settings

Post-obit the process described in the overview paper [21] besides as on the Brighton Collaboration Website http://www.brightoncollaboration.org/cyberspace/en/index/process.html, the Brighton Collaboration Low nascency weight Working Group was formed in 2016 and included 16 members of varied backgrounds including clinical, academic, public health and industry. The composition of the working and reference grouping as well as results of the web-based survey completed past the reference group with subsequent discussions in the working group tin can exist viewed at: http://www.brightoncollaboration.org/cyberspace/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 nativity 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 Depression nascence weight post-obit immunization. 30-two manufactures with potentially relevant material were reviewed in more detail, in order to identify studies using case definitions or, in their absence, providing clinical descriptions of the case textile. This review resulted in a detailed summary of xix manufactures, including data on the study type, the vaccine, the diagnostic criteria or case definition put forth, the time interval since time of immunization, and any other symptoms. Multiple general medical, pediatric and infectious disease book chapters were also searched.

The definition of low birth weight used was consistent across all literature reviewed.

A second literature search using the search terms 'nativity weight and tools' was performed using Pubmed, to identify other measurements used every bit proxies for birth weight. The search, unrestricted for language and twelvemonth of publication, identified in 235 results. Titles were screened and ten articles were identified for further review.

ane.iii. Rationale for selected decisions about the example definition of depression birth weight as an agin event following maternal immunization

1.3.i. The term low nativity weight

'Low birth weight' (LBW) has been defined equally first weight recorded within hours of birth of <2500 chiliad. Very low nascency weight (VLBW) is accepted as <1500 g and extremely low birth weight (ELBW) is <1000 m [ane].

Inside the definition context, even so, the three diagnostic levels must not be misunderstood as reflecting different grades of clinical severity. They instead reflect diagnostic certainty.

The levels of certainty have been formulated such that the Level 1 definition is highly specific for the condition. Ii additional diagnostic levels take been included in the definition, offering a stepwise loss of precision and accuracy from Level One downward to Level Three, while retaining an arroyo to expand utilization of available data. In this way it is hoped that information on low birth weight tin can be captured more broadly at the population level.

one.three.ii. Timing of birth weight cess

The birth weight is described as the commencement weight measured, however, in settings with depression rates of facility-based deliveries, a newborn may not exist assessed by a health intendance worker until several days sometime. Birth weight should be assessed within hours of nativity, prior to significant weight loss [37]. Term neonates lose between 3.5% and 6.6% of their birth weight within the start 2.v–2.7 days of life. Exclusively breastfed neonates have a greater weight loss (Median 6.half-dozen%, 95%CI 6.iii–6.nine%) than formula-fed (Median 3.5%, 95%CI 3.0–iii.9%) or mixed fed (5.9%, 95%CI 4.viii–6.9%) neonates respectively, and take longer to regain their nativity weight (8.three vs. 6.5 vs. 7.9 days) [37].

The LBW working group decided to restrict 'nascence weight' to a weight measured in the starting time 48 h of life. In the absence of a weight measured within the starting time 48 h of life, a weight measured during the commencement week of life, could be classified as an 'early neonatal weight' but not 'birth weight'.

In a clinical trial scenario, measurement of weight inside commencement 48 h of life should exist achievable, as the clinical trial would procure adequate equipment, utilize and train staff to assess birth weight in a timely manner, and enroll participants who reside in areas which are relatively hands accessed past trial or health care staff.

Many newborns globally are non weighed within hours of birth, mainly due to difficulty in accessing health care personnel, facilities, and essential equipment. Specific time frames for onset of symptoms post-obit immunization are not included for the following primary reasons:

We postulate that a definition designed to be a suitable tool for testing causal relationships requires ascertainment of the event (e.1000. low birth weight) independent from the exposure (eastward.chiliad. immunizations). Therefore, to avert option bias, a restrictive time interval from immunization to birth of a LBW newborn should not exist an integral part of such a definition. Instead, where feasible, details of this interval should be assessed and reported every bit described in the data drove guidelines.

Farther, measurement of birth weight often occurs outside the controlled setting of a clinical trial or hospital. In some settings it may be impossible to obtain a articulate timeline of the assessment of a birth weight, particularly in less adult or rural settings. In gild to avoid selecting against such cases, the Brighton Collaboration case definition avoids setting arbitrary time frames. The time between commitment and measurement of birth weight should exist recorded and accounted for in the analysis.

1.four. Guidelines for data drove, analysis and presentation

Every bit mentioned in the overview newspaper [38], the case definition is accompanied by guidelines which are structured according to the steps of conducting a clinical trial, i.eastward. data collection, assay and presentation. Neither case definition nor guidelines are intended to guide or institute criteria for management of sick infants, children, or adults. Both were developed to ameliorate standardization of case definitions and data comparability.

one.5. Periodic review

Like to all Brighton Collaboration instance definitions and guidelines, review of the definition with its guidelines is planned on a regular basis (i.east. every three to v years) or more ofttimes if needed.

2. Case definition of low birth weightthree

Level i of diagnostic certainty

Newborn babe weighed within 24 h of birth AND
Employ electronic scale which is graduated to 10 g AND
Scale is calibrated at least in one case a year AND
Scale placed on level, hard surface AND
Scale tared to zero grams AND
Weight recorded every bit <2500 1000 OR
Birth weight recorded as <2500 g AND
Birth weight assessed as per health care facility'due south standard operating procedure, which fulfills criteria one to 5 of LOC1

Level 2 of diagnostic certainty

Newborn infant weighed within 24 h of nativity AND
Scale (electronic/spring) is graduated to at least fifty thou AND
Scale is calibrated at least in one case a yr, or more ofttimes if moved AND
Calibration tared to zero grams or 0.00 kg AND
Weight recorded as <2500 one thousand OR
Birth weight recorded as <2500 m AND
Birth weight assessed as per health care facility's standard operating procedure, which fulfills criteria ane to 4 of LOC2

Scale used: could be electronic or spring calibration, including color-coded calibration.

Level 3 of diagnostic certainty

Newborn infant weighed on day 1 or 2 of life (first 48 h of life) AND
Weight measured using dial/bound/color-coded scale AND
Weight assessed as <2500 g

Level 4 of diagnostic certainty

Newborn infant 'weight' assessed on 24-hour interval 1 or 2 of life (first 48 h of life) AND
Proxy measure of nativity weight used AND
Weight CATEGORY assessed as <2500 grand

In many settings, including high-income countries, birth weight is assessed past a wellness care provider who is bellboy during/before long after delivery, and not the vaccine trialist/researcher. The details of time of birth weight assessment, and details of scale used and calibration details are usually not recorded in newborn assessment medical notes.

The newborn weight assessment is presumed to exist assessed accurately as per health intendance eye'southward standard operating procedures. In many instances, trialists need to rely on the attention medical staff at health care facility for birth weight assessment. Strengthening grooming and oversight of birth weight measurement would be expected to strengthen information both in clinical trials and post-marketing surveillance.

2.1. Other tools under investigation to estimate birth weight in individuals and populations

Up to sixty million infants are born at dwelling house annually [39], and up to 48% of infants worldwide are not weighed at birth [three]. Lack of access to health care facilities or health care workers hampers accurate assessment of low nascence weight rates in many regions. In order to identify modest newborns, who could exist preterm, IUGR, or both, who require additional care, cheap tools are required which tin be utilized in the field.

The lack of data available has encouraged the development of a mathematical model to calculate the expected number of adverse events, including neonatal and maternal deaths, SGA, preterm birth and major congenital malformations [xl].

Several anthropometric measurements, including chest circumference, pes length and mid-upper arm circumference, have been assessed as proxies for nascence weight [41], [42], [43], [44]. Table 1 summarizes these tools and their validity for identifying low nativity weight newborns. These tools at this signal are considered investigational and accept been included in level iv definition only, which indicates that evidence is inadequate to encounter the definition, nonetheless, may exist useful for population groundwork LBW estimates.

Tabular array one

Validated tools used every bit proxy measures of nativity weight.

Measurement Method of cess Cut-off values used Comments
Newborn foot length [41], [42], [43], [46] Human foot length from center of heel pad to tip of big toe in millimeters Hard plastic ruler pressed vertically confronting sole of foot (highest AUC) 7.2 cm for 2000 thousand Weakest correlation with LBW of all anthropometric measurements [47], [48]
Sole of human foot placed on solid lath with measuring tape seven.8 cm for preterm [41]
⩽7.4 cm (7.3–7.iv cm) for 2500 g [43] AUC 0.94, 95%CI 0.92–0.96 [43]
For <2500 one thousand
Footprint made on White paper, and tip of big toe and heel marked with pencil 7.two cm (Europe) <8 cm at nascence was 87% sensitive for LBW [46]
6.iii–7.85 cm (Asia)
7.four–eight cm (Africa)
Chest circumference [42], [43] Breast circumference at level of nipples in centimeters Non-elastic, flexible measuring tape graduated to nearest 0.1 cm, measured during expiration ⩽xxx.iv cm (30.0–30.4 cm) [43] Highly predictive of LBW if measured at <24 h of historic period (AUC 0.98, 95%CI 0.96–0.99) [43]
In meta-assay, best anthropometric measurement to predict LBW [47]
Gamble of hypothermia
Mid upper arm circumference [43] Mid-point between tip of acromion process and olecranon process in centimeters Non-elastic, flexible measuring tape graduated to nearest 0.i cm ⩽9.0 cm (8.7–9.0 cm) [43] Highly predictive of LBW if measured at <24 h of historic period (AUC 0.98, 95%CI 0.96–0.99) [43]

In addition to these measurements, other tools are utilized in some communities to assess birth weight, including divergence between adult weight with and without newborn in arms (see Fig. ane).

An external file that holds a picture, illustration, etc. Object name is gr1.jpg

Tools used to measure birth weight (Meet above-mentioned references for farther information.).

3. Guidelines for information drove, assay and presentation of low birth weight

Information technology was the consensus of the Brighton Collaboration Working Group for Low birth weight to recommend the following guidelines to enable meaningful and standardized collection, analysis, and presentation of information about low birth weight. All the same, implementation of all guidelines might not be possible in all settings. The availability and quality of data may vary depending upon resources, geographical region, and whether the source of information is a prospective clinical trial, epidemiological report, postal service-marketing surveillance, or an individual study. Also, as explained in more detail in the overview paper [38], these guidelines accept been developed by this working grouping for guidance but, and are not to exist considered a mandatory requirement for data drove, assay, or presentation.

three.1. Information collection

These guidelines represent a desirable standard for the collection of data on availability following immunization to let for comparability of data, and are recommended as an addition to information nerveless for the specific study question and setting. The guidelines are not intended to guide the primary reporting of low nativity weight to a surveillance system or study monitor. Investigators developing a information collection tool based on these data collection guidelines likewise need to refer to the criteria in the case definition, which are not repeated in these guidelines.

Guidelines numbers below have been developed to address data elements for the collection of agin event information equally specified in general drug safety guidelines by the International Briefing on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Apply [49], and the form for reporting of drug agin events by the Quango for International Organizations of Medical Sciences [50]. These data elements include an identifiable reporter and patient, one or more prior immunizations, and a detailed clarification of the adverse effect, in this instance, of low birth weight following immunization. The additional guidelines have been developed as guidance for the collection of boosted information to permit for a more than comprehensive understanding of depression birth weight post-obit maternal immunization.

3.i.1. Source of data/reporter

For all cases and/or all study participants, every bit appropriate, the post-obit information should be recorded:

  • (1)

    Date of report.

  • (ii)

    Name and contact data of person reporting4 and/or diagnosing low nativity weight equally specified by country-specific data protection police.

  • (3)

    Name and contact information of the investigator responsible for the subject area, as applicative.

  • (4)

    Relation to the patient (e.m., healthcare provider, immunizer, community health worker, family member [point human relationship], other).

3.1.2. Vaccinee/control

3.1.2.1. Demographics

For all cases and/or all study participants, as advisable, the following information should be recorded:

  • (5)

    Case/report participant identifiers for mother and newborn (e.g. first proper name initial followed past last name initial) or code (i.east. infirmary identifier or in accordance with country-specific data protection laws). Each newborn should have a unique identifier, ideally linked to mother's identifier (e.m. participant code could exist same for mother and baby(ies), with an added prefix/suffix to identify mother/baby).

  • (6)

    Maternal engagement of nascence, or if non available, maternal age.

  • (seven)

    For each infant: Date and time of delivery, single or multiple, live nascency vs. fetal death (fresh or macerated), estimated gestational historic period, method of determination of gestational historic period (LMP, fundal height, commencement trimester ultrasound) and nascence weight.

    • • For collection of birth weight, ideally tape timeline of weight measurement (e.k. time of delivery to fourth dimension of weight), type of scale used (e.g. surface-mounted spring) and identify where birth weight was measured (e.g. health intendance facility, mobile wellness worker visiting home).
3.one.2.2. Clinical and immunization history

For all cases and/or all written report participants, as advisable, the following information should be recorded:

  • (8)

    Maternal past medical history, including hospitalizations, gravidity and parity, underlying diseases/disorders; complications of pregnancy, labor, or commitment; 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.

  • (ix)

    Any medication history (other than treatment for the upshot described) prior to, during, and after immunization including prescription and non-prescription medication besides every bit medication or treatment with long half-life or long term effect. (E.one thousand. immunoglobulins, blood transfusion and immunosuppressants).

  • (x)

    Immunization history (i.due east. previous immunizations and any agin result following immunization (AEFI)), in detail occurrence of low nascency weight after a previous maternal immunization.

3.1.3. Details of the immunization

For all cases and/or all written report participants, every bit appropriate, the following data should be recorded:

  • (xi)

    Date and time of maternal immunization(due south).

  • (12)

    Clarification of vaccine(s) (name of vaccine, manufacturer, lot number, dose (e.grand. 0.25 mL, 0.5 mL), vaccine diluent (limerick and lot number) and number of dose if part of a serial of immunizations against the same disease).

  • (thirteen)

    The anatomical sites (including left or right side) of all immunizations (e.g. vaccine A in proximal left lateral thigh, vaccine B in left deltoid).

  • (14)

    Road and method of assistants (east.g. intramuscular, intradermal, subcutaneous, and needle-free (including blazon and size), other injection devices).

  • (fifteen)

    Needle length and gauge.

3.i.iv. The adverse outcome

  • (16)

    For all cases at any level of diagnostic certainty and for reported events with insufficient evidence, the criteria fulfilled to run into the case 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 past medico/other health care worker).

  • (xviii)

    Date/time of observation,5 and diagnosis.vi

  • (nineteen)

    Concurrent signs, symptoms, and diseases, including prematurity.

  • (20)

    Measurement/testing.

    • • Values and units of routinely measured parameters (grams for birth weight);
    • • Method of measurement (east.k. blazon of scale.);
    • • Weight should be recorded with minimal or ideally no vesture;

  • (21)

    Objective clinical testify supporting classification of the consequence as "serious".7

  • (22)

    Exposures other than the immunization 24 h before and after immunization (eastward.g. infection, environmental) considered potentially relevant to the reported outcome.8

3.i.5. Miscellaneous/general

  • (23)

    The duration of surveillance for low birth weight should be from 0 to 48 h of life. Any weight measured subsequently 48 h of age should not be considered a 'birth weight'.9

  • (24)

    Methods of data collection should exist consistent within and between study groups, if applicable.10

  • (25)

    Investigators of patients with low birth weight should provide guidance to reporters to optimize the quality and completeness of information provided.

3.2. Data analysis

The post-obit guidelines stand for a desirable standard for analysis of data on low birth weight to let for comparability of information, and are recommended equally an addition to data analyzed for the specific study question and setting.

  • (26)

    Reported events should exist classified in one of the following five categories including the three levels of diagnostic certainty. Events that meet the case definition should be classified according to the levels of diagnostic certainty every bit specified in the case definition. Events that do not run across the case definition should be classified in the boosted categories for analysis.

Consequence classification in 5 categories

Event meets example definition

  • (1)

    Level 1: Criteria as specified in the Depression nascence weight instance definition

  • (2)

    Level two: Criteria as specified in the Low birth weight example definition

  • (3)

    Level 3: Criteria as specified in the Low nascency weight case definition

Event does not meet case definition

Boosted categories for analysis

  • (four)

    Reported Low birth weight with insufficient prove to see the case definition.seven

  • (v)

    Birth weight not assessed, therefore data unavailable.

  • (27)

    The interval between immunization and reported Depression birth weight could be defined as the engagement/time of immunization to the appointment/time of assessmentfour of birth weight. If few cases are reported, the concrete time class could be analyzed for each; for a large number of cases, data tin be analyzed in the following increments.

  • (28)

    If nascency weight is assessed by more than ane method, the value recorded which fulfills the highest level of certainty should be used as the basis for analysis.

  • (29)

    The distribution of birth weight data could be analyzed in predefined increments (eastward.g. LBW < 2500 g, VLBW < 1500 g, ELBW < 1000 g). Increments specified above should be used. When only a small number of cases are presented, the respective values tin can exist presented individually.

  • (30)

    Data on Low nascency weight obtained from participants whose mothers received a vaccine should be compared with those obtained from an appropriately selected and documented control group to assess background rates of LBW in not-exposed populations, and should exist analyzed by study arm and dose where possible, e.g. in prospective clinical trials.

iii.3. Information presentation

These guidelines represent a desirable standard for the presentation and publication of data on Low nascency weight following immunization to permit for comparability of data, and are recommended as an add-on to information presented for the specific written report question and setting. Additionally, it is recommended to refer to existing general guidelines for the presentation and publication of randomized controlled trials, systematic reviews, and meta-analyses of observational studies in epidemiology (e.thou. statements of Consolidated Standards of Reporting Trials (Consort) [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 Depression birth weight should exist presented according to the categories listed in guideline 31.

  • (32)

    Data on Low nascence weight events should be presented in accordance with data collection guidelines 1–25 and data analysis guidelines 26–30.

  • (33)

    Data should be presented equally rates with a numerator and denominator (n/Due north) (and not only in percentages), with confidence intervals around the point estimates.

Although immunization safety surveillance systems denominator information are normally not readily available, attempts should be made to identify approximate denominators. The source of the denominator data should be reported and calculations of estimates be described (eastward.k. manufacturer data like total doses distributed, reporting through Ministry of Health, coverage/population based information, etc.).

  • (34)

    The incidence of cases in the study population should exist presented and clearly identified as such in the text.

  • (35)

    If the distribution of nativity weight data is skewed, median and range are ordinarily the more than appropriate statistical descriptors than a hateful. Still, the mean and standard difference should also be provided.

  • (36)

    Any publication of information on Depression nascence weight should include a detailed clarification of the methods used for data collection and analysis as possible. It is essential to specify:

    • • The study blueprint;
    • • The method, frequency and duration of monitoring for Low birth weight;
    • • The trial profile, indicating participant menstruum during a study including drop-outs and withdrawals to indicate the size and nature of the respective groups under investigation;
    • • The blazon of surveillance (e.one thousand. passive or agile surveillance);
    • • The characteristics of the surveillance arrangement (e.g. population served, manner of written report solicitation);
    • • The search strategy in surveillance databases;
    • • Comparison group(s), if used for analysis;
    • • The musical instrument of data collection (e.thou. standardized questionnaire, diary bill of fare, written report form);
    • • Whether the day of immunization was considered "24-hour interval one" or "twenty-four hours zero" in the analysis;
    • • Whether the date of onset4 and/or the date of starting time ascertainmentfive and/or the date of diagnosis6 was used for analysis; and
    • • Use of this case definition for Low birth weight, in the abstract or methods department of a publication.xi

Disclaimer

The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional person members of the working grouping. They practice not necessarily represent the official positions of each participant's organization (eastward.yard., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily correspond the views of their respective institutions.

Acknowledgements

The authors are grateful for the support and helpful comments provided by the Brighton Collaboration Steering Committee and Reference group, likewise equally other experts consulted equally part of the process. 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 low nascency weight" literature search. The authors are also grateful to Jan Bonhoeffer, Jorgen Bauwens of the Brighton Collaboration Secretariat and Sonali Kochhar of Global Healthcare Consulting for final revisions of the final document.

Footnotes

3The case definition should be practical when there is no clear alternative diagnosis for the reported event to account for the combination of symptoms.

4If the reporting middle is different from the vaccinating center, appropriate and timely communication of the agin event should occur.

5The engagement and/or time of observation is defined equally the time mail immunization, when the Low nascency weight was recorded.

6The engagement of diagnosis of an episode is the day mail immunization when the result met the example definition at any level.

sevenAn AEFI is divers as serious by international standards if it meets one or more than of the following criteria: (1) information technology results in death, (ii) is life-threatening, (three) it requires inpatient hospitalization or results in prolongation of existing hospitalization, (4) results in persistent or significant disability/incapacity, (5) is a congenital bibelot/birth defect, (half-dozen) is a medically important outcome or reaction.

8To determine the advisable category, the user should starting time establish, whether a reported result meets the criteria for the lowest applicative level of diagnostic certainty, e.g. Level three. If the lowest applicative level of diagnostic certainty of the definition is met, and in that location is show that the criteria of the next higher level of diagnostic certainty are met, the outcome should exist classified in the next category. This approach should be connected until the highest level of diagnostic certainty for a given event could be determined. Major criteria can be used to satisfy the requirement of minor criteria. If the lowest level of the case definition is non met, it should be ruled out that whatever of the higher levels of diagnostic certainty are met and the event should be classified in additional categories four or 5.

ixIf the evidence available for an event is insufficient because data is missing, such an result should be categorized as "Reported Low birth weight with insufficient evidence to meet the instance definition".

10An effect does not run into the example definition if investigation reveals a negative finding of a necessary benchmark (necessary condition) for diagnosis. Such an issue should be rejected and classified as "Not a case of Depression birth weight".

elevenApply of this document should preferably be referenced by referring to the respective link on the Brighton Collaboration website (http://world wide web.brightoncollaboration.org).

Appendix ASupplementary data associated with this article can be constitute, in the online version, at https://doi.org/10.1016/j.vaccine.2017.01.049.

Appendix A. Supplementary material

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