- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504863
RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study (RAPIDIRON-KIDS)
Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
Study Overview
Status
Intervention / Treatment
Detailed Description
The RAPIDIRON-KIDS Study has two primary hypotheses:
- 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
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Simal Thind, MD, MPH
- Phone Number: 2674499181
- Email: simal.thind@jefferson.edu
Study Contact Backup
- Name: Jesse Bradford-Rogers, MPH
- Email: jesse.bradford-rogers@jefferson.edu
Study Locations
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Karnataka
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Bagalkot, Karnataka, India
- S. Nijalingappa Medical College
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Contact:
- Ashalata Mallapur, MD
- Phone Number: +91 99456 99986
- Email: drashalatamallapur@gmail.com
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Contact:
- Umesh Ramadurg, MD
- Email: umeshramadurg79@gmail.com
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Belgaum, Karnataka, India
- Jawaharlal Nehru Medical College
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Contact:
- M B Bellad, MD
- Phone Number: +91 94481 24893
- Email: mbbellad@hotmail.com
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Contact:
- Roopa B Bellad, MD
- Email: belladroopa5@gmail.com
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Raichur, Karnataka, India
- Raichur Institute of Medical Sciences
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Contact:
- Radha Sangavi, MD
- Phone Number: +91 99020 59441
- Email: radhasangavi16@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
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.
Other Names:
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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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Offspring hemoglobin
Time Frame: Birth
|
Offspring hemoglobin concentration in g/dL
|
Birth
|
Offspring hemoglobin
Time Frame: 4 months of age
|
Offspring hemoglobin concentration in g/dL
|
4 months of age
|
Offspring ferritin
Time Frame: Birth
|
Offspring serum ferritin concentration in ng/mL
|
Birth
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Offspring ferritin
Time Frame: 4 months of age
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Offspring serum ferritin concentration in ng/mL
|
4 months of age
|
Cognitive Domain of Bayley Scales of Infant Development (BSID)
Time Frame: 24 months of age
|
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.
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24 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Offspring hemoglobin
Time Frame: 12 months of age
|
Offspring hemoglobin concentration in g/dL
|
12 months of age
|
Offspring ferritin
Time Frame: 12 months of age
|
Offspring serum ferritin concentration in ng/mL
|
12 months of age
|
Preferential Looking Time
Time Frame: 4 and 12 months of age
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Performance on Preferential Looking Time assessment - scored as the percentage of time spent looking at the novel object during the test phase
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4 and 12 months of age
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Motor and language domains of the Bayley Scales of Infant Development (BSID)
Time Frame: 24 months of age
|
Developmental quotient (DQ) on the motor and language domains of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age.
The motor domain of the BSID-IV contains 79 items, and the language domain contains 104 items.
Minimum score on each item is 0, maximum score is 2. A lower score is a bad outcome and a higher score is a good outcome.
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24 months of age
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Bayley Scales of Infant Development (BSID)
Time Frame: 36 months of age
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Developmental quotients (DQs) on all domains of the Bayley Scales of Infant Development (BSID), conducted at 36 months of age.
There are 5 domains, each many items.
Each item has 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.
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36 months of age
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Behavior Rating Scale
Time Frame: 24 months of age
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Score on the Behavior Rating Scale, as coded from a video recording undergoing the Bayley Scales of Infant Development (BSID).
Each child is rated across nine behavioral domains.
The minimum score in each domain is 0 and the maximum score is 5, with higher scores indicating more optimal behaviors.
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24 months of age
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Ages & Stages Questionnaire 3
Time Frame: 12 months of age
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Accepted and validated screening tool for neurodevelopment.
Minimum score of 0, maximum score of 60.
Lower score is a bad outcome, higher score is a good outcome.
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12 months of age
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Child Behavior Checklist for Ages 1.5-5
Time Frame: 24 and 36 months of age
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A parent-report questionnaire assessing internalizing and externalizing behaviors.
Standardized t-scores will result, with a mean of 50 and standard deviation of 10.
Higher scores indicate more symptoms (emotional/behavioral) and a worse outcome.
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24 and 36 months of age
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India Scale of Assessment for Autism
Time Frame: 36 months of age
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A standardized screening tool for autism, validated for the Indian population.
40 items are rated from 1 to 5, with a higher score indicating increasing severity.
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36 months of age
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Offspring weight
Time Frame: 4, 12, 24, and 36 months of age
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Offspring weight measured in kg
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4, 12, 24, and 36 months of age
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Offspring height
Time Frame: 6 weeks, 4, 12, 24, and 36 months of age
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Offspring height measured in cm
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6 weeks, 4, 12, 24, and 36 months of age
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Offspring head circumference
Time Frame: Birth, 4, 12, 24, and 36 months of age
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Offspring head circumference measured in cm
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Birth, 4, 12, 24, and 36 months of age
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Infant and Young Child Feeding Practices
Time Frame: Birth, 6 weeks, 4, 12, and 24 months of age
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A composite questionnaire used to measure feeding practices based upon breastfeeding, dietary diversity, meal frequency, iron supplementation, and iron-fortified foods.
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Birth, 6 weeks, 4, 12, and 24 months of age
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Maternal hemoglobin concentration
Time Frame: 4, 12, and 24 month visits
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Maternal hemoglobin concentration measured in g/dL
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4, 12, and 24 month visits
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Maternal ferritin
Time Frame: 4, 12, and 24 month visits
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Maternal serum ferritin concentration in ng/mL
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4, 12, and 24 month visits
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Maternal well-being/quality of life
Time Frame: 4 and 12 month visits
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Maternal well-being/quality of life, as measured by the World Health Organization Disability Assessment Schedule II (WHODAS-II).
Uses 36 items to measure health and disability across six domains of life - cognitive, mobility, self care, relationship, life activities, and participation.
Each item is given a score from 0 to 4, and all item scores are summed.
Higher scores mean worse outcomes and higher disability status.
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4 and 12 month visits
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Offspring hospitalization
Time Frame: Birth to 3 years of age
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Incidence of offspring hospitalization
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Birth to 3 years of age
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Maternal hospitalization
Time Frame: Birth to 3 years
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Incidence of maternal hospitalization
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Birth to 3 years
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Maternal transfusions
Time Frame: Birth to 3 years
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Incidence of maternal blood transfusions
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Birth to 3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Derman, MD, MPH, Thomas Jefferson University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2111-07169
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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