Health Condition 1: P229- Respiratory distress of newborn, unspecified
Conditions
Interventions
Intervention1: Azithromycin: Dose-2 g
Frequency-Single dose
Route of administration-Oral Duration of therapy-A single, prophylactic
intrapartum oral dose of
azithromycin
Control Intervention1: Place
Sponsors
Thrasher Research Foundation
Eligibility
Inclusion criteria
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
Exclusion criteria: Prenatally or postnatally diagnosed or suspected genetic disorders, neurologic diseases, and other diseases that affect neurodevelopment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BSID-III Cognitive Composite Score (CCS) at 24(plus or minus 1) months corrected ageTimepoint: 24 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia
Contacts
Public ContactDr Shivaprasad S Goudar
J N Medical College, KLE Academy of Higher Education and Research
Outcome results
None listed