Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

Recruiting Phase 4 Interventional Study
Premature Infant Disease Apnea of Prematurity Development, Infant
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 Days – 12 Months
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
340 (estimated)
Sponsor
University of Alabama at Birmingham · Other
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About This Trial
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 ho…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Newborns: 1. 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, 2. On methylxanthines with plans to discontinue on methylxanthine, 3. Off oxygen therapy for \>48 hours at the time of evaluation for eligib…
Contacts

Albert Manasyan, MD

+260 976 448 994

Albert.Manasyan@cidrz.org

CONTACT

Waldemar A Carlo, MD

2059344680

wacarlo@uabmc.edu

CONTACT