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. 2023 Dec 20;24(1):818.
doi: 10.1186/s13063-023-07740-z.

RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study

Richard J Derman  1 , Roopa B Bellad  2 , Mrutyunjaya B Bellad  2 , Jesse Bradford-Rogers  3 , Michael K Georgieff  4 , Zubair H Aghai  5 , Simal Thind  1 , Michael Auerbach  6 , Rupsa Boelig  1 , Benjamin E Leiby  1 , Vanessa Short  1 , S Yogeshkumar  2 , Umesh S Charantimath  2 , Manjunath S Somannavar  2 , Ashalata A Mallapur  7 , Ramesh Pol  7 , Umesh Ramadurg  7 , Radha Sangavi  8 , Basavaraj V Peerapur  8 , Nasima Banu  8 , Praveen S Patil  8 , Amaresh P Patil  2 , Subarna Roy  9 , Phaniraj Vastrad  9 , Dennis Wallace  1 , Hemang Shah  10 , Shivaprasad S Goudar  2
Affiliations

RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study

Richard J Derman et al. Trials. .

Abstract

Background: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes.

Methods: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age.

Discussion: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes.

Trial registration: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Keywords: Anemia; Anemia in pregnancy; Iron deficiency anemia; Neurodevelopment.

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Conflict of interest statement

The authors disclose the following:

• Richard Derman currently receives research funding from the Children’s Investment Fund Foundation (CIFF), the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), the Bill & Melinda Gates Foundation (BMGF), and the Thrasher Research Fund.

• Michael Auerbach receives grant funding from Pharmacosmos and Covis and has received payment for educational, non-promotional programs on the use of IV iron from Pharmacosmos, Pfizer, and American Regent.

• Rupsa Boelig receives grant funding from Covis, NIH, March of Dimes, Thrasher Research Fund, and Pharmacosmos.

• Michael Georgieff receives grant funding from NIH, CIFF, and BMGF.

• Mrutyunjaya B. Bellad received 100 doses each of ferric carboxymaltose (FCM) and ferric derisomaltose (FDM) from the local distributors (Emcure and Lupin respectively) free of cost for thesis (postgraduate research study) work of one of the OBGYN Residents.

• Benjamin Leiby receives grant funding from CIFF, NIH, BMGF, and GlaxoSmithKline, and serves on a DSMB for Alpha Tau Medical.

References

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    1. International Institute for Population Sciences. National Family Health Survey-5, 2019–21, India Fact Sheet. Government of India, Ministry of Health and Family Welfare. 2022. https://rchiips.org/nfhs/NFHS-5_FCTS/India.pdf.
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