Higher caffeine dose to improve breathing in extremely premature babies
Official title: Caffeine Optimization for Oxygen Saturation Index in ELBW Infants (COFIE Trial)
Run by University of Rochester · NCT07216365 · Data updated 2026-11-12
This trial tests whether giving caffeine citrate at 10 mg/kg helps oxygenation in extremely premature infants compared with the standard 5 mg/kg dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 0 Days to 27 Weeks |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | July 15, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07216365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Inborn preterm infants born between 22 0/7 and 27 6/7 weeks, or those under 1000 g birthweight at URMC with no major exclusions.
✕Probably not a fit
Infants with severe congenital anomalies, non-survivable conditions within 72 hours, hepatic failure, NEC, or other exclusions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial compares two maintenance doses of caffeine citrate in extremely preterm infants (<28 weeks gestation or very low birthweight) to see if a higher dose improves oxygenation and reduces serious respiratory and neurodevelopmental complications. Researchers will measure oxygen saturation and related outcomes, while monitoring for safety signals such as tachycardia or growth issues. The study uses two parallel groups receiving either 5 mg/kg or 10 mg/kg caffeine citrate, started in the neonatal period. Eligible participants include inborn ELGANs admitted to the enrolling center, with several medical exclusions applied. The trial is led by the University of Rochester and conducted at URMC, focusing on optimizing caffeine therapy for better respiratory support in this vulnerable population.
Why it matters
Potential benefit: If successful, higher-dose caffeine citrate could improve breathing and reduce risk of lung or brain injury in ELGAN infants.
How similar studies have gone: Prior caffeine studies support respiratory benefits in prematurity, but optimal dosing for safety and efficacy remains to be confirmed in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * URMC Inborn Newborn infants born with gestational age of 22 weeks 0 days - 27 weeks 6 days or infants OR ≥ 28 weeks with a birthweight \< 1000 grams Exclusion Criteria: * Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congenital or genetic anomalies, infants not anticipated to survive beyond 72 hours, infants with mothers that are non-English speaking or \<18 years old at time of enrollment.
Where it's running
-
University of Rochester Medical Center
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Stephanie C Vachon, DO
- Email: stephanie_vachon@urmc.rochester.edu
- Phone: (585) 275-4174
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.