Neuroimaging Ancillary Study

NCT05545527 | Completed DMC

• 1 other identifier: U32401
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.

Conditions

Iron Deficiency Anemia; Iron Deficiency Anemia of Pregnancy; Neurodevelopmental Disorder of Foetus; Iron Deficiency Anemia Treatment; Fetal Neurodevelopmental Disorder; Child Development

Keywords

India; Neuroimaging; Intravenous iron; MRI; Pediatrics

Outcome Measures

Primary Outcomes (3)

• Fetal hippocampal volume

  Fetal hippocampus volume, measured via fetal MRI

  32-35 weeks fetal gestational age

• Fetal diffusion parameters: fractional anisotropy (FA)

  Fetal white matter microstructure will be measured via FA at the posterior limb of internal capsule using fetal MRI

  32-35 weeks fetal gestational age

• Fetal diffusion parameters: mean diffusivity

  Fetal white matter microstructure will be measured via MD at the posterior limb of internal capsule using fetal MRI

  32-35 weeks fetal gestational age

Secondary Outcomes (8)

• Fetal sub-cortical gray matter structures

  32-35 weeks fetal gestational age

• Fetal white matter microstructure measures

  32-35 weeks fetal gestational age

• Child hippocampal volume

  4 - 24 months of age

• Child white matter volume

  4 - 24 months of age

• Child white matter microstructure

  4 - 24 months of age

Other Outcomes (8)

• Child auditory brain response (ABR) results

  Birth - 4 months of age

• Hair cortisol results

  Birth

• Maternal depression

  Measured from 32-35 weeks fetal gestational age - 24 months offspring age

Study Arms (3)

RAPIDIRON IV iron intervention arm 1

Maternal participants in this arm were given a single dose of an IV iron formulation - ferric carboxymaltose - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.

Drug: Ferric carboxymaltose

RAPIDIRON IV iron intervention arm 2

Maternal participants in this arm were given a single dose of an IV iron formulation - iron isomaltoside - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.

Drug: Iron isomaltoside

RAPIDIRON active comparator arm

Maternal participants in this arm of the RAPIDIRON Trial were given ferrous sulfate tablets with 60mg elemental iron each and instructed to take two per day (one in the morning and one at night) throughout their pregnancy.

Drug: Ferric Sulfate

Interventions

Ferric carboxymaltose DRUG

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.

RAPIDIRON IV iron intervention arm 1

Iron isomaltoside DRUG

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.

Also known as: Ferric derisomaltose

RAPIDIRON IV iron intervention arm 2

Ferric Sulfate DRUG

As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (\~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.

Also known as: Ferric sulphate

RAPIDIRON active comparator arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

For this ancillary study, only infants of randomized RAPIDIRON Trial (NCT05358509) participants recruited in Karnataka State will be eligible for participation.

You may qualify if:

• For the maternal participant in the parent RAPIDIRON Trial - a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age)
• An indication of the pregnant woman's intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
• Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in this ancillary trial; and
• Concurrent participation in the RAPIDIRON-KIDS follow-up study (NCT05504863).

You may not qualify if:

• If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
• If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Jawaharlal Nehru Medical College: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; iron isomaltoside 1000; ferric derisomaltose; ferric sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Richard Derman, MD, MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: February 21, 2023
• Primary Completion: February 14, 2024
• Study Completion: April 7, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

IN (1)