Effect of azithromycin on neurodevlopment in children of two years who does not cry at birth
Not Applicable
- Conditions
- Health Condition 1: P229- Respiratory distress of newborn, unspecified
- Registration Number
- CTRI/2022/06/043138
- Lead Sponsor
- Thrasher Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Survivor of birth asphyxia (more than or equal to 34 weeks of gestational age) with no, mild, moderate or severe hypoxic ischemic encephalopathy (categorized by neurological examination using the Modified Sarnat Score) born to a mother who received either a single oral dose of 2 grams of azithromycin or placebo during labor as part of the A-PLUS RCT and willing to participate in neurodevelopmental assessment at 24(plus or minus 1) months of age.
Birth asphyxia is defined as any of the following- received positive pressure ventilation at birth and or a 5-min Apgar score less than 7
Exclusion Criteria
Prenatally or postnatally diagnosed or suspected genetic disorders, neurologic diseases, and other diseases that affect neurodevelopment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BSID-III Cognitive Composite Score (CCS) at 24(plus or minus 1) months corrected ageTimepoint: 24 months of age
- Secondary Outcome Measures
Name Time Method ASQ-3 and the Family Care Indicators questionnaire at 24(plus or minus 1) months corrected ageTimepoint: 24 months of age;Childrens outcome- Neurodevlopment outcome by gender, stunting, Infant Child Feeding Index and breastfeeding durationTimepoint: 24 months of age