NCT07216365 · University of Rochester
Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
(COFIE trail)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Caffeine Citrate
High Dose Group: Caffeine citrate administered as a 20 mg/kg loading dose followed by a 10 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion. Standard Dose Group: Caffeine citrate administered as a 20 mg/kg loading dose followed by a 5 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.
Primary outcome measures
Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days
Time frame: From Randomization to Day 56 or Caffeine Discontinuation
The OSI is calculated as (FiO₂ × MAP × 100) / SpO₂. The average OSI per patient will be calculated from randomization through the first 56 days or until caffeine is discontinued or the patient is discharged. Higher OSI values indicate worse oxygenation.
Total Duration of Respiratory Support
Time frame: From Randomization to 1 year
Total number of days each patient receives any respiratory support, including invasive ventilation, CPAP, or supplemental oxygen.
Total Incidence of Severe Bronchopulmonary Dysplasia (BPD)
Time frame: From Randomization to 1 year
Number of infants diagnosed with severe BPD based on NICHD criteria.
Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH/PVL)
Time frame: From Randomization to 1 year
Number of infants diagnosed with severe IVH (Grade III/IV) or PVL based on cranial imaging.
Total Length of NICU Stay
Time frame: Birth to 1 year
Total number of days each infant remains in the NICU from birth until discharge.
Total Number of Infant Deaths
Time frame: From Randomization to 1 year
Number of infants who die before NICU discharge.
Total Test of Infant Motor Performance (TIMP) Score Prior to Discharge
Time frame: Prior to NICU Discharge
TIMP is a 42-item motor development assessment. Each item scores from 0 to 6. Total scores range from 0 to 252. Higher scores indicate better motor performance.
Total Duration of SpO₂ Below Threshold (Intermittent Hypoxia)
Time frame: From Randomization through Day 56
Cumulative minutes with SpO₂ below target threshold, derived from Neo-DReAMS repository.
Total Time with Heart Rate >180 bpm (Tachycardia)
Time frame: From Randomization to 1 year
Total minutes with heart rate exceeding 180 bpm recorded via monitor.
Total Growth Parameter Z-Scores (Length, Weight, Head Circumference)
Time frame: From Randomization to 1 year
Growth will be assessed using Fenton z-scores. Higher scores reflect better growth relative to gestational norms.
Total Osteopenia Markers (Alkaline Phosphatase, Calcium, Phosphorus)
Time frame: From Randomization to 1 year
Osteopenia assessed by abnormal lab values: alkaline phosphatase \>500 IU/L, abnormal calcium or phosphorus. Abnormal values per infant will be summed.
Total Incidence of Hypertension (>95th Percentile)
Time frame: From Randomization to 1 year
Number of days with blood pressure \>95th percentile for gestational age.
Total Time to Full Enteral Feeds
Time frame: From Randomization to 1 year
Days from birth until the infant reaches 120 mL/kg/day enteral nutrition.
Total Number of NPO Periods >24 Hours
Time frame: From Randomization through NICU Discharge
Number of times infant is NPO (nothing by mouth) for more than 24 hours.
Total Incidence of Necrotizing Enterocolitis (NEC)
Time frame: From Randomization to 1 year
Number of infants diagnosed with NEC (Bell's stage II or higher).
Total Incidence of Spontaneous Intestinal Perforation (SIP)
Time frame: From Randomization to 1 year
Number of infants with radiographically or surgically confirmed SIP.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations