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Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

Study acronym: COFIE trail
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Sep 1, 2027 → Jul 1, 2028
See other at-risk trials from University of Rochester

Record History

  1. Notable Primary completion pushed from Sep 1, 2027 to Jul 1, 2028v4 Show 4 more changesShow less
    • Recruitment opened
    • Study completion pushed from Sep 1, 2028 to Sep 1, 2029
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2026 to Jul 15, 2026
  2. Notable Start date: Mar 1, 2026 to Jun 1, 2026
    • Study completion pushed from Sep 1, 2027 to Sep 1, 2028
    v3
  3. Notable Start date: Nov 1, 2025 to Mar 1, 2026v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine whether a higher dose of caffeine citrate can improve breathing and reduce health complications in extremely premature infants, specifically those born before 28 weeks of pregnancy, known as ELGAN infants. These babies often struggle with breathing due to underdeveloped lungs, and caffeine is commonly used to help support their respiratory function. However, the most effective and safest dose has not yet been clearly established. The study aims to answer two main questions: Does a higher maintenance dose of caffeine (10 mg/kg) lead to better oxygenation, as measured by the Oxygen Saturation Index (OSI), compared to the standard dose (5 mg/kg)? And does the higher dose reduce the risk of serious complications such as lung disease, brain injury, or death-without causing more side effects like fast heart rate, high blood pressure, or poor growth? To answer these questions, researchers will compare two groups of infants: one receiving the high-dose caffeine treatment and the other receiving the standard dose. This comparison will help determine if the higher dose leads to better outcomes without increased risk. Participants will begin caffeine treatment once they have regained their birth weight and are at least seven days old. They will be randomly assigned to receive either the high or standard caffeine dose and will be followed until caffeine is stopped or they are discharged from the hospital. During this time, researchers will monitor each infant's oxygenation levels, need for breathing support, signs of common complications, growth and feeding progress, and any side effects. Before discharge, each infant's motor development will also be assessed using a tool called the Test of Infant Motor Performance (TIMP). This study could help define the most effective caffeine dosing strategy for supporting extremely premature infants and improving their short-term health outcomes.
Trial Details
NCT Number NCT07216365
Lead Sponsor University of Rochester
Conditions
(from sponsor)
Neonatal Apnea, Infants
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov