RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study

NCT05504863 | Unknown DMC

• 1 other identifier: R-2111-07169
• Study Type: observational
• Target: 538
• Locations: 1 country
• Sites: 3

Brief Summary

As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.

Conditions

Iron Deficiency Anemia; Neurodevelopmental Abnormality; Autism Spectrum Disorder

Keywords

Anemia; Iron Deficiency Anemia; Intravenous iron; India; Low birth weight; Pediatrics; Neurodevelopment

Outcome Measures

Primary Outcomes (5)

• Offspring hemoglobin

  Offspring hemoglobin concentration in g/dL

  Birth

• Offspring hemoglobin

  Offspring hemoglobin concentration in g/dL

  4 months of age

• Offspring ferritin

  Offspring serum ferritin concentration in ng/mL

  Birth

• Offspring ferritin

  Offspring serum ferritin concentration in ng/mL

  4 months of age

• Cognitive Domain of Bayley Scales of Infant Development (BSID)

  Developmental quotient (DQ) on the cognitive domain of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age. The Cognitive Domain of the BSID-IV contains 81 items, each item with a minimum score of 0 and a maximum score of 2. A lower score is a bad outcome and a higher score is a good outcome.

  24 months of age

Secondary Outcomes (16)

• Offspring hemoglobin

  12 months of age

• Offspring ferritin

  12 months of age

• Preferential Looking Time

  4 and 12 months of age

• Motor and language domains of the Bayley Scales of Infant Development (BSID)

  24 months of age

• Bayley Scales of Infant Development (BSID)

  36 months of age

Other Outcomes (3)

• Offspring hospitalization

  Birth to 3 years of age

• Maternal hospitalization

  Birth to 3 years

• Maternal transfusions

  Birth to 3 years

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

Participants of this study are mother-infant dyads consisting of women, residing in Karnataka State (India), who were randomized and treated for iron-deficiency anemia (IDA) during the RAPIDIRON Trial and their newborns.

You may qualify if:

• Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research are for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits
• For the offspring - live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother

You may not qualify if:

• Unwillingness of maternal participant to provide RAPIDIRON-KIDS Study consent for herself and her offspring

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Jawaharlal Nehru Medical College: collaborator
• S. Nijalingappa Medical College: collaborator
• Raichur Institute of Medical Sciences: collaborator

Study Sites (3)

S. Nijalingappa Medical College

Bagalkot, Karnataka, India

Location

Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Location

Raichur Institute of Medical Sciences

Rāichūr, Karnataka, India

Location

Related Publications (1)

• Derman RJ, Bellad RB, Bellad MB, Bradford-Rogers J, Georgieff MK, Aghai ZH, Thind S, Auerbach M, Boelig R, Leiby BE, Short V, Yogeshkumar S, Charantimath US, Somannavar MS, Mallapur AA, Pol R, Ramadurg U, Sangavi R, Peerapur BV, Banu N, Patil PS, Patil AP, Roy S, Vastrad P, Wallace D, Shah H, Goudar SS. RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study. Trials. 2023 Dec 20;24(1):818. doi: 10.1186/s13063-023-07740-z.

  PMID: 38124098 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Autism Spectrum Disorder; Anemia

Interventions

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

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

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: July 20, 2022
• First Posted: August 17, 2022
• Study Start: October 11, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

IN (3)