Clinical trial NCT05504863: RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study
Official title: Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Iron Deficiency Anemia
Neurodevelopmental Abnormality
Autism Spectrum Disorder
Keywords: Anemia
Iron Deficiency Anemia
Intravenous iron
India
Low birth weight
Pediatrics
Neurodevelopment
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College
name: S. Nijalingappa Medical College
name: Raichur Institute of Medical Sciences
First posted: 2022-08-17
Enrollment: 538
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The RAPIDIRON-KIDS Study has two primary hypotheses:

1. Infants born to RAPIDIRON Trial maternal participants from the intravenous (IV) iron arms will have higher hemoglobin and ferritin levels at birth (determined by cord blood) and at 4 months of age compared to infants born to mothers in the oral arm; and
2. Offspring born to RAPIDIRON Trial participants who received IV iron treatment will have higher developmental quotients (DQs) on the cognitive domain of the Bayley Scales of Infant Development (BSID) at 2 years of age compared to offspring born to RAPIDIRON Trial participants given oral iron treatment.

The specific aims of this study are as follows:

* To provide evidence that a single-dose of IV iron (either ferric carboxymaltose or iron isomaltoside, also known as ferric derisomaltose) given to pregnant women in the second trimester during the RAPIDIRON Trial will prove more effective for prevention of neonatal and postnatal iron deficiency in the offspring than the oral iron given to pregnant women per the parent trial protocol
* To assess if the offspring of women in the parent trial IV iron arms have better neurodevelopmental outcomes compared to the offspring of women treated with oral iron; and
* To determine longer-term hematologic effects in previously randomized mothers by obtaining ongoing hematologic indices, documented history of transfusion and hospitalization, and quality of life based on the use of a validated instrument.

This study will recruit pregnant mothers currently participating in the RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in the RAPIDIRON-KIDS Study. Participation in RAPIDIRON-KIDS will involve assessments at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months of age. In addition to iron status, anthropometry, and questionnaires relating to child feeding and maternal quality of life, the following neurobehavioral tests will be utilized to assess the offspring at various timepoints: Preferential Looking Test, Ages \& Stages Questionnaire 3, Bayley Scales of Infant Development, Behavioral Rating Scale, India Scale for Assessment of Autism, and the Child Behavior Checklist for Ages 1.5-5.

Please see the protocol for additional details.

Eligibility criteria: Inclusion Criteria:

* Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study
* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Offspring hemoglobin
timeFrame: Birth
measure: Offspring hemoglobin
timeFrame: 4 months of age
measure: Offspring ferritin
timeFrame: Birth
measure: Offspring ferritin
timeFrame: 4 months of age
measure: Cognitive Domain of Bayley Scales of Infant Development (BSID)
timeFrame: 24 months of age
Secondary outcomes:
measure: Offspring hemoglobin
timeFrame: 12 months of age
measure: Offspring ferritin
timeFrame: 12 months of age
measure: Preferential Looking Time
timeFrame: 4 and 12 months of age
measure: Motor and language domains of the Bayley Scales of Infant Development (BSID)
timeFrame: 24 months of age
measure: Bayley Scales of Infant Development (BSID)
timeFrame: 36 months of age
measure: Behavior Rating Scale
timeFrame: 24 months of age
measure: Ages & Stages Questionnaire 3
timeFrame: 12 months of age
measure: Child Behavior Checklist for Ages 1.5-5
timeFrame: 24 and 36 months of age
measure: India Scale of Assessment for Autism
timeFrame: 36 months of age
measure: Offspring weight
timeFrame: 4, 12, 24, and 36 months of age
measure: Offspring height
timeFrame: 6 weeks, 4, 12, 24, and 36 months of age
measure: Offspring head circumference
timeFrame: Birth, 4, 12, 24, and 36 months of age
measure: Infant and Young Child Feeding Practices
timeFrame: Birth, 6 weeks, 4, 12, and 24 months of age
measure: Maternal hemoglobin concentration
timeFrame: 4, 12, and 24 month visits
measure: Maternal ferritin
timeFrame: 4, 12, and 24 month visits
measure: Maternal well-being/quality of life
timeFrame: 4 and 12 month visits
Other outcomes:
measure: Offspring hospitalization
timeFrame: Birth to 3 years of age
measure: Maternal hospitalization
timeFrame: Birth to 3 years
measure: Maternal transfusions
timeFrame: Birth to 3 years
Locations:
city: Bagalkot
country: India
facility: S. Nijalingappa Medical College
state: Karnataka
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
state: Karnataka
city: Raichur
country: India
facility: Raichur Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: Thomas Jefferson University
name: Richard Derman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: