Autism Spectrum Disorder Clinical Trial
— RAPIDIRON-KIDSOfficial title:
Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
Verified date | November 2023 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 538 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | S. Nijalingappa Medical College | Bagalkot | Karnataka |
India | Jawaharlal Nehru Medical College | Belgaum | Karnataka |
India | Raichur Institute of Medical Sciences | Raichur | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Jawaharlal Nehru Medical College, Raichur Institute of Medical Sciences, S. Nijalingappa Medical College |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Offspring hospitalization | Incidence of offspring hospitalization | Birth to 3 years of age | |
Other | Maternal hospitalization | Incidence of maternal hospitalization | Birth to 3 years | |
Other | Maternal transfusions | Incidence of maternal blood transfusions | Birth to 3 years | |
Primary | Offspring hemoglobin | Offspring hemoglobin concentration in g/dL | Birth | |
Primary | Offspring hemoglobin | Offspring hemoglobin concentration in g/dL | 4 months of age | |
Primary | Offspring ferritin | Offspring serum ferritin concentration in ng/mL | Birth | |
Primary | Offspring ferritin | Offspring serum ferritin concentration in ng/mL | 4 months of age | |
Primary | 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 | Offspring hemoglobin | Offspring hemoglobin concentration in g/dL | 12 months of age | |
Secondary | Offspring ferritin | Offspring serum ferritin concentration in ng/mL | 12 months of age | |
Secondary | Preferential Looking Time | Performance on Preferential Looking Time assessment - scored as the percentage of time spent looking at the novel object during the test phase | 4 and 12 months of age | |
Secondary | Motor and language domains of the Bayley Scales of Infant Development (BSID) | 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. | 24 months of age | |
Secondary | Bayley Scales of Infant Development (BSID) | 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. | 36 months of age | |
Secondary | Behavior Rating Scale | 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. | 24 months of age | |
Secondary | Ages & Stages Questionnaire 3 | 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. | 12 months of age | |
Secondary | Child Behavior Checklist for Ages 1.5-5 | 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. | 24 and 36 months of age | |
Secondary | India Scale of Assessment for Autism | 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. | 36 months of age | |
Secondary | Offspring weight | Offspring weight measured in kg | 4, 12, 24, and 36 months of age | |
Secondary | Offspring height | Offspring height measured in cm | 6 weeks, 4, 12, 24, and 36 months of age | |
Secondary | Offspring head circumference | Offspring head circumference measured in cm | Birth, 4, 12, 24, and 36 months of age | |
Secondary | Infant and Young Child Feeding Practices | A composite questionnaire used to measure feeding practices based upon breastfeeding, dietary diversity, meal frequency, iron supplementation, and iron-fortified foods. | Birth, 6 weeks, 4, 12, and 24 months of age | |
Secondary | Maternal hemoglobin concentration | Maternal hemoglobin concentration measured in g/dL | 4, 12, and 24 month visits | |
Secondary | Maternal ferritin | Maternal serum ferritin concentration in ng/mL | 4, 12, and 24 month visits | |
Secondary | Maternal well-being/quality of life | 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. | 4 and 12 month visits |
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