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Deep clinical and biological phenotyping of the preterm birth and small for gestational age syndromes: The INTERBIO-21 st Newborn Case-Control Study protocol.

Kennedy, SH; Victora, CG; Craik, R; Ash, S; Barros, FC; Barsosio, HC; Berkley, JA; Carvalho, M; Fernandes, M; Cheikh Ismail, L; et al. Kennedy, SH; Victora, CG; Craik, R; Ash, S; Barros, FC; Barsosio, HC; Berkley, JA; Carvalho, M; Fernandes, M; Cheikh Ismail, L; Lambert, A; Lindgren, CM; McGready, R; Munim, S; Nellåker, C; Noble, JA; Norris, SA; Nosten, F; Ohuma, EO; Papageorghiou, AT; Stein, A; Stones, W; Tshivuila-Matala, COO; Staines Urias, E; Vatish, M; Wulff, K; Zainab, G; Zondervan, KT; Uauy, R; Bhutta, ZA; Villar, J (2018) Deep clinical and biological phenotyping of the preterm birth and small for gestational age syndromes: The INTERBIO-21 st Newborn Case-Control Study protocol. Gates Open Res, 2. p. 49. ISSN 2572-4754 https://doi.org/10.12688/gatesopenres.12869.2
SGUL Authors: Papageorghiou, Aris

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Abstract

Background: INTERBIO-21 st is Phase II of the INTERGROWTH-21 st Project, the population-based, research initiative involving nearly 70,000 mothers and babies worldwide coordinated by Oxford University and performed by a multidisciplinary network of more than 400 healthcare professionals and scientists from 35 institutions in 21 countries worldwide. Phase I, conducted 2008-2015, consisted of nine complementary studies designed to describe optimal human growth and neurodevelopment, based conceptually on the WHO prescriptive approach. The studies generated a set of international standards for monitoring growth and neurodevelopment, which complement the existing WHO Child Growth Standards. Phase II aims to improve the functional classification of the highly heterogenous preterm birth and fetal growth restriction syndromes through a better understanding of how environmental exposures, clinical conditions and nutrition influence patterns of human growth from conception to childhood, as well as specific neurodevelopmental domains and associated behaviors at 2 years of age. Methods: In the INTERBIO-21 st Newborn Case-Control Study, a major component of Phase II, our objective is to investigate the mechanisms potentially responsible for preterm birth and small for gestational age and their interactions, using deep phenotyping of clinical, growth and epidemiological data and associated nutritional, biochemical, omic and histological profiles. Here we describe the study sites, population characteristics, study design, methodology and standardization procedures for the collection of longitudinal clinical data and biological samples (maternal blood, umbilical cord blood, placental tissue, maternal feces and infant buccal swabs) for the study that was conducted between 2012 and 2018 in Brazil, Kenya, Pakistan, South Africa, Thailand and the UK. Discussion: Our study provides a unique resource for the planned analyses given the range of potentially disadvantageous exposures (including poor nutrition, pregnancy complications and infections) in geographically diverse populations worldwide. The study should enhance current medical knowledge and provide new insights into environmental influences on human growth and neurodevelopment.

Item Type: Article
Additional Information: Copyright: © 2019 Kennedy SH et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: INTERBIO-21st, INTERGROWTH-21st, SGA, fetal growth, preterm birth
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: Gates Open Res
ISSN: 2572-4754
Language: eng
Dates:
DateEvent
4 October 2018Published
5 February 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
49038Bill and Melinda Gates Foundationhttp://dx.doi.org/10.13039/100000865
PubMed ID: 31172050
Go to PubMed abstract
URI: http://sgultest.da.ulcc.ac.uk/id/eprint/111355
Publisher's version: https://doi.org/10.12688/gatesopenres.12869.2

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