Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caffeine Citrate.
- Who it may be relevant to
- Registry conditions: Neonatal Apnea, Infants. Basic parameters: 0 Days — 27 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Caffeine Optimization for Oxygen Saturation Index in ELBW Infants (COFIE Trial)
Overview
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
Primary outcome measures
- Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days [Time frame: From Randomization to Day 56 or Caffeine Discontinuation]
- Total Duration of Respiratory Support [Time frame: From Randomization to 1 year]
- Total Incidence of Severe Bronchopulmonary Dysplasia (BPD) [Time frame: From Randomization to 1 year]
- Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH/PVL) [Time frame: From Randomization to 1 year]
- Total Length of NICU Stay [Time frame: Birth to 1 year]
- Total Number of Infant Deaths [Time frame: From Randomization to 1 year]
- Total Test of Infant Motor Performance (TIMP) Score Prior to Discharge [Time frame: Prior to NICU Discharge]
- Total Duration of SpO₂ Below Threshold (Intermittent Hypoxia) [Time frame: From Randomization through Day 56]
- Total Time with Heart Rate >180 bpm (Tachycardia) [Time frame: From Randomization to 1 year]
- Total Growth Parameter Z-Scores (Length, Weight, Head Circumference) [Time frame: From Randomization to 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07216365 · STUDY00011029