Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
None listed
Sponsors
Childrens Investment Fund Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1 Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study 2 Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research area for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits 3 For the offspring â?? live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother and cord blood is available for analysis
Exclusion criteria
Exclusion criteria: For the offspring: 1 Non-availability of cord blood at birth to enable determination of iron indices 2 Fetal anomaly discovered after the first ultrasound of the RAPIDIRON Trial 3 Major congenital anomalies and congenital malformation of central nervous system noted at birth 4 Congenital infection 5 Moderate to severe hypoxic ischemic encephalopathy For the RAPIDIRON Trial participant (mother): 1 Lack of availability of hemoglobin concentration from a blood sample drawn prior to delivery â?? either at the last RAPIDIRON Trial visit before delivery (visit 7 at 30-34 weeks of pregnancy) or just prior to delivery 2 Unwillingness to provide RAPIDIRON-KIDS Study consent for herself and her offspring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Offspring Primary Outcomes: (1)Iron status â?? indicated by hemoglobin, ferritin at birth and at 4 months (2)Developmental quotients (DQs) for the Bayley Scales of Infant Development (BSID) at 24 monthsTimepoint: At birth, 4 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Documented blood transfusions of motherTimepoint: through three years post-delivery;DQ on Developmental Ability Scales-II (DAS-II)Timepoint: 36 months;Growth parameters (weight, length/height, and head circumference)Timepoint: 4, 12, 24, and 36 months;Hospitalizations and aetiologiesTimepoint: during the first three years of the childâ??s life;Hospitalizations of motherTimepoint: through three years post-delivery;Infant feeding practicesTimepoint: during the first three years of the childâ??s life;Infant feeding practices of motherTimepoint: through three years post-delivery;Internalizing and Externalizing behaviors on the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)Timepoint: 12, 24, and 36 months;Iron status â?? indicated by hemoglobin, ferritin, and other indicesTimepoint: 12, 24 and 36 months;Iron status of motherTimepoint: 4, 12, 24, and 36 months;Performance on Ages & Stages Questionnaire-3 (ASQ-3)Timepoint: 4,12, 24 and 36 months;Performance on Behavioral Rating ScaleTimepoint: 12 and 24 months;Performance on Preferential Looking assessmentTimepoint: 4 and 12 months;Quality of life indices of motherTimepoint: 4, 12, and 24 months;Risk of autism diagnosis on Indian Scale of AutismTimepoint: 36 months;Scoring of performance on mother/language/cognitive domains of BSIDTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed