Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.
Our research questions are:
1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?
2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?
Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.
Parents of participants will:
1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge
2. Keep a diary of symptoms and any apneic events
3. Check in with researchers via telephone call once a week
4. Return to clinic for infant physical examination at 28 days
5. Return to the clinic for infant physical examination at 2 months
5\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age
Phase:
PHASE4
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
Centre for Infectious Disease Research in Zambia University Teaching Hospital, Lusaka, Zambia