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. 2024 Feb 8;25(1):110.
doi: 10.1186/s13063-024-07942-z.

Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial)

Ranadip Chowdhury  1 , Rukman Manapurath  1   2 , Ingvild Fossgard Sandøy  2   3 , Ravi Prakash Upadhyay  1 , Neeta Dhabhai  1 , Saijuddin Shaikh  1 , Harish Chellani  1 , Tarun Shankar Choudhary  1   3 , Abhinav Jain  4 , Jose Martines  3 , Nita Bhandari  1 , Tor A Strand  2   5 , Sunita Taneja  6 ; Small Babies Trial Group
Affiliations

Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial)

Ranadip Chowdhury et al. Trials. .

Abstract

Background: Preterm and term small for gestational age (SGA) babies are at high risk of experiencing malnutrition and impaired neurodevelopment. Standalone interventions have modest and sometimes inconsistent effects on growth and neurodevelopment in these babies. For greater impact, intervention may be needed in multiple domains-health, nutrition, and psychosocial care and support. Therefore, the combined effects of an integrated intervention package for preterm and term SGA on growth and neurodevelopment are worth investigating.

Methods: An individually randomized controlled trial is being conducted in urban and peri-urban low to middle-socioeconomic neighborhoods in South Delhi, India. Infants are randomized (1:1) into two strata of 1300 preterm and 1300 term SGA infants each to receive the intervention package or routine care. Infants will be followed until 12 months of age. Outcome data will be collected by an independent outcome ascertainment team at infant ages 1, 3, 6, 9, and 12 months and at 2, 6, and 12 months after delivery for mothers.

Discussion: The findings of this study will indicate whether providing an intervention that addresses factors known to limit growth and neurodevelopment can offer substantial benefits to preterm or term SGA infants. The results from this study will increase our understanding of growth and development and guide the design of public health programs in low- and middle-income settings for vulnerable infants.

Trial registration: The trial has been registered prospectively in Clinical Trial Registry - India # CTRI/2021/11/037881, Registered on 08 November 2021.

Keywords: Child health; Early child stimulation; Growth failure; Intrauterine growth restriction; Responsive stimulation; Small for gestational age; Small vulnerable newborns; preterm.

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Conflict of interest statement

The authors declare that they have no competing interests.

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Trial profile
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References

    1. Lee AC, Kozuki N, Cousens S, Stevens GA, Blencowe H, Silveira MF, Sania A, Rosen HE, Schmiegelow C, Adair LS, et al. Estimates of burden and consequences of infants born small for gestational age in low and middle income countries with INTERGROWTH-21st standard: analysis of CHERG datasets. BMJ. 2017;358:j3677. doi: 10.1136/bmj.j3677. - DOI - PMC - PubMed
    1. Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019;7(1):e37–e46. doi: 10.1016/S2214-109X(18)30451-0. - DOI - PMC - PubMed
    1. Lawn JE, Ohuma EO, Bradley E, Idueta LS, Hazel E, Okwaraji YB, Erchick DJ, Yargawa J, Katz J, Lee ACC, et al. Small babies, big risks: global estimates of prevalence and mortality for vulnerable newborns to accelerate change and improve counting. Lancet. 2023;401(10389):1707–1719. doi: 10.1016/S0140-6736(23)00522-6. - DOI - PubMed
    1. Blencowe H, Cousens S, Chou D, et al. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. - DOI - PMC - PubMed
    1. Taneja S, Chowdhury R, Dhabhai N, Upadhyay RP, Mazumder S, Sharma S, Bhatia K, Chellani H, Dewan R, Mittal P, et al. Impact of a package of health, nutrition, psychosocial support, and WaSH interventions delivered during preconception, pregnancy, and early childhood periods on birth outcomes and on linear growth at 24 months of age: factorial, individually randomised controlled trial. BMJ. 2022;379:e072046. doi: 10.1136/bmj-2022-072046. - DOI - PMC - PubMed

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