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.
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…
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