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Trial · NCT05504863

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOffspring hemoglobinBirthOffspring hemoglobin concentration in g/dL
PrimaryOffspring hemoglobin4 months of ageOffspring hemoglobin concentration in g/dL
PrimaryOffspring ferritinBirthOffspring serum ferritin concentration in ng/mL
PrimaryOffspring ferritin4 months of ageOffspring serum ferritin concentration in ng/mL
PrimaryCognitive Domain of Bayley Scales of Infant Development (BSID)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.
SecondaryOffspring hemoglobin12 months of ageOffspring hemoglobin concentration in g/dL
SecondaryOffspring ferritin12 months of ageOffspring serum ferritin concentration in ng/mL
SecondaryPreferential Looking Time4 and 12 months of agePerformance on Preferential Looking Time assessment - scored as the percentage of time spent looking at the novel object during the test phase
SecondaryMotor and language domains of the Bayley Scales of Infant Development (BSID)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.
SecondaryBayley Scales of Infant Development (BSID)36 months of age
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.
SecondaryBehavior Rating Scale24 months of age
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.
SecondaryAges & Stages Questionnaire 312 months of ageAccepted 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.
SecondaryChild Behavior Checklist for Ages 1.5-524 and 36 months of age
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.
SecondaryIndia Scale of Assessment for Autism36 months of ageA 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.
SecondaryOffspring weight4, 12, 24, and 36 months of ageOffspring weight measured in kg
SecondaryOffspring height6 weeks, 4, 12, 24, and 36 months of ageOffspring height measured in cm
SecondaryOffspring head circumferenceBirth, 4, 12, 24, and 36 months of ageOffspring head circumference measured in cm
SecondaryInfant and Young Child Feeding PracticesBirth, 6 weeks, 4, 12, and 24 months of ageA composite questionnaire used to measure feeding practices based upon breastfeeding, dietary diversity, meal frequency, iron supplementation, and iron-fortified foods.
SecondaryMaternal hemoglobin concentration4, 12, and 24 month visitsMaternal hemoglobin concentration measured in g/dL
SecondaryMaternal ferritin4, 12, and 24 month visitsMaternal serum ferritin concentration in ng/mL

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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