Health Condition 1: R625- Other and unspecified lack of expected normal physiological development in childhood
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children born to women enrolled in the main ACTION III trial (July 2022 to December 5 2024), who survive the first 28 days of life ACTION III trial enrolls pregnant women with high probability of late preterm birth (GA 34+0 weeks-36+6 weeks) 2. Children between 29d to 33 plus 3 months of age (the main trial is following up the mother-infant dyad for 28d post birth) 3. Parents/ caregivers willing for a 33-month follow-up of their children 4. Parents/ caregivers consent for participation of their child in the follow-up study
Exclusion criteria
Exclusion criteria: 1. Children with major congenital anomaly that would preclude accurate assessment of neurodevelopment 2. Children with medical condition that would preclude accurate assessment of neurodevelopment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global neurodevelopmental status measured as development-for-age z-score (DAZ) using Global Scales for Early Development at 33 plus or minus 3 months. The GSED-DAZ is a continuous age-adjusted z-score.Timepoint: At 33 plus or minus 3 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Hearing impairment assessed by Automated Auditory Brainstem Response (AABR) & Diagnostic BERA (if required) Timepoint: Anytime from discharge to 33 plus or minus 3 months of age;Neuromotor Impairment as assessed by Hammersmith Infant Neurological Exam (HINE)Timepoint: At 12 months to 18 months;Global Development impairment as assessed by Bayley Scales of Infant Development (BSID IV) & Global Scales for Early Development- Short Form & Long Form (GSED SF & GSED LF)Timepoint: At 33 plus or minus 3 months of age;Social Communication Impairment as assessed by AIIMS Modified -INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD)Timepoint: At 33 plus or minus 3 months of age;Behavioral Impairment as assessed by Child Behavior Checklist- 1 -5 (CBCL)Timepoint: At 33 plus or minus 3 months of age;Clinical diagnosis of Epilepsy assessed by AIIMS Modified -INCLEN Diagnostic Tool for Epilepsy (INCLEN-INDT-EPI)Timepoint: At 33 plus or minus 3 months of age;Visual acuity as assessed by Cardiff Card TestTimepoint: At 33 plus or minus 3 months of age;Death and severe illness requiring hospitalizationTimepoint: Any time after a participant dies during the study;Postnatal growth impairment assessed by Anthropometry: Head Circumference, Height & WeightTimepoint: 29d to 3 months, 12 to 18 months, 33 plus or minus 3 months of age;Catastrophic Healthcare Expenditure (CHE) cases averted by interventionTimepoint: At 33 plus or minus 3 months of age;ImpoverishmentTimepoint: At 33 plus or minus 3 months of age;Equity impactTimepoint: At 33 plus or minus 3 months of age;Out of pocket expenditure averted by interventionTimepoint: At 33 plus or minus 3 months of age;Cost per additional disability-adjusted life year (DALY) gainedTimepoint: At 33 plus or minus 3 months of age;Incremental Cost- Effectiveness Ratio (ICER) for ACSTimepoint: At 33 plus or minus 3 months of age;Caregivers health literacy on the early child neurodevelopmentTimepoint: At 33 plus or minus 3 months of age;Impac | — |
Countries
India
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Academy of Higher Education and Researchs J N Medical College
Outcome results
None listed