The ABC (Azithromycin: Brain neuroprotection for Children) Study
Current Research: This study is a prospective, masked, matched study evaluating the neurodevelopmental outcomes of children in the A-PLUS Trial. The ABC Study will enroll 420 birth asphyxiated infants (≥ 34 weeks of gestation) with no, mild, moderate, or severe hypoxic-ischemic encephalopathy (categorized by neurological examination using the Modified Sarnat Score) born to mothers who received either a single oral dose of 2 grams of azithromycin or placebo during labor in the A-PLUS trial, which aims to study the effectiveness of intrapartum azithromycin on reducing maternal and neonatal infections and deaths. Prospective and retrospective enrolled infants will undergo several developmental assessments by trained assessors at 24 (±1) months of corrected age (adjusting for Gestational Age).
The azithromycin RCT (A-PLUS Trial), has provided high level evidence on intrapartum azithromycin's effectiveness in reducing neonatal infections and neonatal mortality. The ABC study will leverage the A-PLUS RCT study design to determine if intrapartum azithromycin reduces neurodevelopmental disabilities at 24 months in survivors of birth asphyxia. Infection- and birth asphyxia-induced inflammatory cascades are challenging to subdue after reaching a critical threshold. Prior research has been limited in its rigor because it investigated neuroprotective strategies' effectiveness after the hypoxic-ischemic brain insult. The ABC Study will excel in its rigor as it will be using a placebo-controlled RCT that exposed the fetuses to azithromycin prior to or early after the intrauterine insult and will use neurodevelopmental assessments by assessors unaware of the treatment exposure and birth history, including the severity of the encephalopathy in the first 24 hours after birth. This experimental design will result in robust and unbiased results. If intrapartum azithromycin is found to be neuroprotective in children who survived birth asphyxia, it could become the intrapartum antibiotic of choice in selected deliveries.