830
Participants
Start Date
June 30, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
July 31, 2030
Caffeine citrate oral solution
Caffeine citrate oral solution will be used and administered by enteral route (oral or by gavage tube). The loading dose (20 mg/kg) will be administered once followed by daily doses of 10 mg per kg body weight every 24 hours for two doses. The study Standard Operating Procedures (SOPs) includes details regarding caffeine preparation based on the participant's body weight.
Oral placebo solution
Identical placebo oral solution
ICDDR,B, Saidpur
Kinshasa School of Public Health, Kinshasa
Institute of Nutrition of Central America And Panama (INCAP), Chimaltenango
KLE University's J N Medical College, Belagavi
Lata Medical Research Foundation, Nagpur
Aga Khan University, Karachi
University Teaching Hospital, Lusaka
RTI International
OTHER
University of North Carolina, Chapel Hill
OTHER
Kinshasa School of Public Health
OTHER
Institute of Nutrition of Central America and Panama (INCAP)
UNKNOWN
Lata Medical Research Foundation, Nagpur
OTHER
Aga Khan University
OTHER
University Teaching Hospital, Lusaka, Zambia
OTHER
KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
UNKNOWN
Bill and Melinda Gates Foundation
OTHER
University of Virginia
OTHER
University of Alabama at Birmingham
OTHER
Thomas Jefferson University
OTHER
Columbia University
OTHER
University of Colorado, Denver
OTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
NICHD Global Network for Women's and Children's Health
NETWORK