CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \[\<1 hour\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg/kg dose of oral caffeine followed by two additional 10 mg/kg doses at 24-hour intervals or placebo of the same regimen (three total doses).
The goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.
Phase:
PHASE3
Details
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborators:
Aga Khan University Bill and Melinda Gates Foundation Columbia University Institute of Nutrition of Central America and Panama (INCAP) International Centre for Diarrhoeal Disease Research, Bangladesh Kinshasa School of Public Health KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India Lata Medical Research Foundation, Nagpur RTI International Thomas Jefferson University University of Alabama at Birmingham University of Colorado, Denver University of North Carolina, Chapel Hill University of Virginia University Teaching Hospital, Lusaka, Zambia