Caffeine Use in the Management of Preterm Infants
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Apnea of Prematurity
In brief
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.
Key facts
- Study ID
- NCT06327152
- Run by
- University of California, Irvine
- People needed
- 80
- Starts
- 2024-02-22
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-11-10
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants born at equal to or less than 32 weeks and 0 days gestational age AND
- Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
- Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
- On caffeine and meet criteria to discontinue caffeine.
- No significant cardiopulmonary events for at least 5 days (apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change).
You may not qualify if…
- Infants with critical congenital heart disease.
- Infants with neuromuscular conditions affecting respiration.
- Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
- Infants with major genetic disorders.
- Infants with anatomic anomalies that will hinder oral feeding.
- Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
- Infants who develop necrotizing enterocolitis after enrollment.
- Failure to obtain consent or declined by parents.
Where it is running
- UC Irvine Medical Center — Orange, California, United States
Full record on ClinicalTrials.gov
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