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1、A Vol 384 September 6,2014 857International standards for newborn weight,length,and head circumference by gestational age and sex:the Newborn Cross-Sectional Study of the INTERGROWTH-21st ProjectJos Villar,Leila Cheikh Ismail,Cesar G Victora,Eric O Ohuma,Enrico Bertino,Doug G Altman,Ann Lambert,Aris
2、 T Papageorghiou,Maria Carvalho,Yasmin A Jaff er,Michael G Gravett,Manorama Purwar,Ihunnaya O Frederick,Alison J Noble,Ruyan Pang,Fernando C Barros,Cameron Chumlea,Zulfi qar A Bhutta*,Stephen H Kennedy*,for the International Fetal and Newborn Growth Consortium for the 21st Century(INTERGROWTH-21st)S
3、ummaryBackground In 2006,WHO published international growth standards for children younger than 5 years,which are now accepted worldwide.In the INTERGROWTH-21st Project,our aim was to complement them by developing international standards for fetuses,newborn infants,and the postnatal growth period of
4、 preterm infants.Methods INTERGROWTH-21st is a population-based project that assessed fetal growth and newborn size in eight geographically defi ned urban populations.These groups were selected because most of the health and nutrition needs of mothers were met,adequate antenatal care was provided,an
5、d there were no major environmental constraints on growth.As part of the Newborn Cross-Sectional Study(NCSS),a component of INTERGROWTH-21st Project,we measured weight,length,and head circumference in all newborn infants,in addition to collecting data prospectively for pregnancy and the perinatal pe
6、riod.To construct the newborn standards,we selected all pregnancies in women meeting(in addition to the underlying population characteristics)strict individual eligibility criteria for a population at low risk of impaired fetal growth(labelled the NCSS prescriptive subpopulation).Women had a reliabl
7、e ultrasound estimate of gestational age using crownrump length before 14 weeks of gestation or biparietal diameter if antenatal care started between 14 weeks and 24 weeks or less of gestation.Newborn anthropometric measures were obtained within 12 h of birth by identically trained anthropometric te
8、ams using the same equipment at all sites.Fractional polynomials assuming a skewed t distribution were used to estimate the fi tted centiles.Findings We identifi ed 20 486(35%)eligible women from the 59 137 pregnant women enrolled in NCSS between May 14,2009,and Aug 2,2013.We calculated sex-specifi
9、c observed and smoothed centiles for weight,length,and head circumference for gestational age at birth.The observed and smoothed centiles were almost identical.We present the 3rd,10th,50th,90th,and 97th centile curves according to gestational age and sex.Interpretation We have developed,for routine
10、clinical practice,international anthropometric standards to assess newborn size that are intended to complement the WHO Child Growth Standards and allow comparisons across multiethnic populations.Funding Bill&Melinda Gates Foundation.IntroductionIn 1994,the main WHO expert committee on the use and i
11、nterpretation of anthropometry recommended the use of international standards to assess anthropometric measures.1,2 To implement these recommendations for infants and children,WHO initiated the Multicentre Growth Reference Study(MGRS).3 In 2006,this study generated WHO Child Growth Standards for chi
12、ldren younger than 5 years,which are now accepted worldwide.4,5 Two characteristics made the WHO MGRS unique and unprecedented:the study included populations from Brazil,Ghana,India,Norway,Oman,and the USA,and it used a prescriptive approach to select the study populations(inclusion of only breast-f
13、ed infants from mothers who did not smoke and who had minimum environmental constraints on growth).6Aiming to complement the WHO MGRS,in 2008 the International Fetal and Newborn Growth Consortium for the 21st Century(INTERGROWTH-21st)launched a multicountry project to develop similar pres criptive s
14、tandards for fetuses,newborn infants,and the postnatal growth of preterm infants.The INTERGROWTH-21st Project was done in eight countries and completed in 2014.7 One of its three main studies(the Newborn Cross-Sectional Study)aimed to produce newborn standards for birthweight,length,and head circumf
15、erence at birth.The approach for the primary analysis8 was based on that used in the WHO MGRS3 to compare the similarities in skeletal size and growth of fetuses and newborn infants.The results of the two studies concur and strongly support pooling of the eight INTERGROWTH-21st populations to constr
16、uct new inter national newborn standards.The large number of size charts for use at birth available(104 published since 1990)and their substantial method-ological heterogeneity and limitations(unpublished data)complicate the clinical assessment of a newborn infants Lancet 2014;384:85768See Comment p
17、age 833*Joint senior authorsMembers listed at the end of this paperNuffi eld Department of Obstetrics and Gynaecology and Oxford Maternal and Perinatal Health Institute,Green Templeton College(Prof J Villar MD,L C Ismail PhD,E O Ohuma MSc,A Lambert PhD,A T Papageorghiou MD,Prof S H Kennedy MD),Centr
18、e for Statistics in Medicine,Botnar Research Centre(E O Ohuma,Prof D G Altman DSc),and Department of Engineering Science(Prof A J Noble DPhil),University of Oxford,Oxford,UK;Programa de Ps-Graduaao em Epidemiologia,Universidade Federal de Pelotas,Pelotas,Brazil(Prof C G Victora MD,Prof F C Barros MD
19、);Dipartimento di Scienze Pediatriche e dellAdolescenza,Cattedra di Neonatologia,Universita degli Studi di Torino,Torino,Italy(Prof E Bertino MD);Faculty of Health Sciences,Aga Khan University,Nairobi,Kenya(M Carvalho MD);Department of Family and Community Health,Ministry of Health,Muscat,Oman(Y A J
20、aff er MD);University of Washington School of Medicine,Seattle,WA,USA(M G Gravett MD);Nagpur INTERGROWTH-21st Research Centre,Ketkar Hospital,Nagpur,India(M Purwar MD);Center for Perinatal Studies,Swedish Medical Center,Seattle,WA,USA(I O Frederick PhD);School of Public Health,Peking University,Beij
21、ing,China(Prof R Pang MD);Programa de Ps-Graduao em Sade e Comportamento,Universidade Catlica de Pelotas,Pelotas,Brazil(Prof F C Barros);Lifespan Health Research Center Boonshoft School of Medicine,Articles858 Vol 384 September 6,2014nutritional status and make comparisons diffi cult across populati
22、ons.Available estimates for the prevalence and mortality of small-for-gestational-age babies show that these assessments are a major priority for public health.911 The absence of an international standard has been a major limitation for such estimates because the many references to choose from were
23、derived from individual countries or regions at particular timepoints.Therefore,development of an international standard for newborn infants is important for clinical practice and essential to estimate accurately the prevalence of small-for-gestational-age babies worldwide.In this Article,we present
24、 such a set of standards.MethodsStudy design and participants INTERGROWTH-21st is a multicentre,multiethnic,population-based project done between April 27,2009,and March 2,2014,in eight study sites:Pelotas,Brazil;Turin,Italy;Muscat,Oman;Oxford,UK;Seattle WA,USA;Shunyi County in Beijing,China;the cen
25、tral area of Nagpur,India;and the Parklands suburb of Nairobi,Kenya.7 The primary aim of the project was to study growth,health,nutrition,and neurodevelopment from 14 weeks of gestation to age 2 years using the same conceptual framework as the WHO MGRS6 to produce prescriptive growth standards and a
26、 new phenotypic classifi cation for intrauterine growth restriction and preterm birth syndromes.12The methods have been described in detail elsewhere.7 Populations were fi rst selected by geographical location and then by individual characteristics.At the population level,we chose an urban area(eg,a
27、 complete city or county,or part of a city with clear political or geographical limits)where most deliveries occurred in health-care facilities serving pregnant women.The areas had to be located at an altitude of 1600 m or lower;women receiving antenatal care had to plan to deliver in these institut
28、ions or in a similar hospital located in the same geographical area;and there had to be an absence or low levels of major,known,non-microbiological contamination such as pollution,domestic smoke due to tobacco or cooking,radiation,or any other toxic substances,assessed during the study period for ea
29、ch site with a data collection form developed specifi cally for the project.13 In the eight areas,we selected all institutions providing pregnancy and intrapartum care in which more than 80%of deliveries in the area occurred.We included all newborn infants delivered in these institutions over 12 mon
30、ths,or until the target sample of 7000 babies per site was attained,using the same standardised data collection forms,electronic data management system,manuals of operation,and instruments.To construct the newborn standards,we divided all pregnancies in NCSS into two groups on the basis of individua
31、l characteristics.The fi rst,named the NCSS prescriptive subpopulation,consisted of all pregnancies and newborn infants of women who met the strict individual eligibility criteria for those at low risk of fetal growth impairment.These demographic,clinical,social,and educational criteria were identic
32、al to those used in the INTERGROWTH-21st Fetal Growth Longitudinal Study to develop the new prescriptive fetal growth standards.7,8 We do not consider the second group(composed of all newborn infants from higher-risk pregnancies)further in this Article.The individual exclusion criteria are presented
33、 elsewhere,7 but comprise maternal age younger than 18 years or older than 35 years,maternal height shorter than 153 cm,body-mass index(BMI)30 kg/m or higher or lower than 185 kg/m,current smoker,medical history,birth of any previous baby weighing less than 25 kg or more than 45 kg,past two pregnanc
34、ies ending in miscarriage,any previous stillbirth or neonatal death,or congenital malformation.To be included in the NCSS prescriptive subpopulation,in addition to meeting individual clinical and demographic criteria,women needed a reliable ultrasound estimate of gestational age from a measurement o
35、f crownrump length before 14 weeks of gestation or biparietal diameter when antenatal care started between 14 and 24 weeks of gestation.All participating hospitals agreed to a policy of routinely estimating gestational age by ultrasound after a strict,standardised protocol.When ultrasound estimation
36、 was made after 24 weeks of gestation,which occurred in only 82%of women,it was only accepted as reliable if any diff erence between this estimated gestational age and the one based on the last menstrual period was 7 days or less.14 We also recommended a policy of a more liberal use of delayed cord
37、clamping,15,16 which was implemented in the facilities where most births occurred.However,uptake was lower in hospitals with many private obstetricians,and some clinicians expressed concerns about the increased risk of neonatal jaundice and delayed neonatal care.No information was available at the i
38、ndividual patient level.The INTERGROWTH-21st Project was approved by the Oxfordshire Research Ethics Committee“C”(reference 08/H0606/139),the research ethics committees of the individual participating institutions,and the corresponding regional or national health authorities where the project was do
39、ne.We obtained institutional consent to use routinely collected data and women gave oral consent.ProceduresNCSS anthropometric teams,who were specially recruited,trained,and standardised for the study,exclusively obtained the anthropometric measures of the newborn infants.The teams took measurements
40、 within 12 h of birth using identical equipment that we provided to all sitesan electronic scale(Seca,Hangzhou,China)for birthweight,a specially designed Harpenden infantometer(Chasmors,London,UK)for recumbent length,and a metallic non-extendable tape(Chasmors)for head circumference.17 The equipment
41、,which was Wright State University,Dayton,OH,USA(Prof C Chumlea PhD);Division of Women and Child Health,The Aga Khan University,Karachi,Pakistan(Prof Z A Bhutta PhD);and Center for Global Health,Hospital for Sick Children,Toronto,ON,Canada(Prof Z A Bhutta)Correspondence to:Prof Jos Villar,Nuffi eld
42、Department of Obstetrics and Gynaecology,University of Oxford,John Radcliff e Hospital,Oxford OX3 9DU,UKjose.villarobs-A Vol 384 September 6,2014 859calibrated twice a week,was selected for accuracy,precision,and robustness,as shown in previous studies.18Measurement procedures were standardised on t
43、he basis of WHO recommendations to ensure maximum validity.18 During the standardisation sessions,the intraobserver and interobserver error of measurement values for recumbent length ranged from 03 to 05 cm,and those for head circumference ranged from 03 to 04 cm.Each measurement was collected indep
44、endently by two study anthropometrists.19 If the diff erence between the two measurements exceeded the maximum allowable diff erence(birthweight 5 g,length 7 mm,and head circumference 5 mm),then both observers independently retook that measurement a second time and,if necessary,a third time.The trai
45、ning,standardisation,monitoring processes,and quality control methods used across all sites are described in detail elsewhere.17,19 Neonatal clinical practices(including those for care in neonatal intensive care units and for feeding)were standardised across sites to follow a basic package of intern
46、ationally accepted evidence-based practices following an agreed protocol adopted by the projects neonatal study group and promoted across all participating hospitals.20The data processing and management systems are described in detail elsewhere.21 All documentation used in the INTERGROWTH-21st Proje
47、ct was tested locally and introduced into the specially developed online electronic data entry,cleaning,and management system hosted by MedSciNet.Data were entered locally directly onto the web-based system,and we used the average values of the repeated anthropometric measures.The percentage of time
48、s that measurements were taken only once was 24%for birthweight,01%for length,and 10%for head circumference.In this small number of cases we used that measure in the analysis.During data cleaning,we excluded 75 measures(17 for birthweight,26 for length,and 32 for head circumference),because they wer
49、e either implausible within each study sites distribution or they were not within fi ve SDs of the mean of the overall gestational-age-specifi c values.We excluded 15 newborn infants whose gestational age was older than 44 weeks of gestation.Statistical analysisTo select the statistical methods to c
50、onstruct our standards,we used the same strategy as the WHO MGRS,22 complemented by published work23,24 and our systematic review of neonatal charts.We explored the following four methods:fi rst,a mean and SD method using fractional polynomials;25 second,a lambda(),mu(),and sigma(;LMS)method,2628 wh