Status:
NOT_YET_RECRUITING
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University Teaching Hospital, Lusaka, Zambia
Centre for Infectious Disease Research in Zambia
Conditions:
Premature Infant Disease
Apnea of Prematurity
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE4
Brief 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...
Detailed Description
Once an infant has been deemed stable by the neonatologist and the neonatologist recommends discontinuing treatment for apnea of prematurity 5 days before hospital discharge as per standard of care, t...
Eligibility Criteria
Inclusion
- Newborns:
- 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,
- On methylxanthines with plans to discontinue on methylxanthine,
- Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
- Receiving full daily feeds,
- Deemed stable and ready to go off caffeine as recommended by the Neonatologist
- 18+ years of age (parent)
Exclusion
- Newborns with neuromuscular conditions affecting respiration,
- Major congenital malformations and genetic disorders,
- Unable to obtain parental or guardian consent
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06518603
Start Date
January 1 2026
End Date
December 31 2026
Last Update
September 5 2025
Active Locations (1)
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1
University Teaching Hospital
Lusaka, Lusaka Province, Zambia, 10100