Using caffeine to help preterm infants feed better
Caffeine Use in the Management of Preterm Infants
PHASE2 · University of California, Irvine · NCT06327152
This study is testing if giving extra caffeine to preterm infants can help them start feeding by mouth faster than those who don’t get the caffeine.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Week to 40 Weeks |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06327152 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether extending caffeine therapy can help preterm infants achieve full oral feeding more quickly. It is a randomized, double-blinded, placebo-controlled trial where infants will receive either caffeine or a placebo for up to four additional weeks after meeting criteria to stop caffeine. The initiation of oral feeding will follow standard care protocols, and the time taken to reach full oral feeds will be compared between the two groups. The study aims to provide insights into the effectiveness of prolonged caffeine use in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born at or before 32 weeks gestational age who are ready to discontinue caffeine therapy.
Not a fit: Patients with critical congenital heart disease or significant neuromuscular conditions affecting respiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster feeding progress in preterm infants, potentially improving their overall health outcomes.
How similar studies have performed: Previous studies have shown promising results with caffeine therapy in preterm infants, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • 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). Exclusion Criteria: * 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 this trial is running
Orange, California
- UC Irvine Medical Center — Orange, California, United States (RECRUITING)
Study contacts
- Principal investigator: Cherry Uy, MD — UC Irvine
- Study coordinator: Rosie Magallon
- Email: rmagallo@hs.uci.edu
- Phone: 714-509-6082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Apnea of Prematurity, Feeding, Caffeine