Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-27
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Caffeine Citrate
DrugHigh 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: High Dose Caffeine ArmExperimental treatment 1 intervention
Group B: Standard Dose Caffeine ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average Oxygen Saturation Index (OSI) per Patient Over First 56 Days
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.
Time frame
From Randomization to Day 56 or Caffeine Discontinuation2
Total Duration of Respiratory Support
Total number of days each patient receives any respiratory support, including invasive ventilation, CPAP, or supplemental oxygen.
Time frame
From Randomization to 1 year3
Total Incidence of Severe Bronchopulmonary Dysplasia (BPD)
Number of infants diagnosed with severe BPD based on NICHD criteria.
Time frame
From Randomization to 1 year4
Total Incidence of Severe Intraventricular Hemorrhage or Periventricular Leukomalacia (IVH/PVL)
Number of infants diagnosed with severe IVH (Grade III/IV) or PVL based on cranial imaging.
Time frame
From Randomization to 1 yearSponsors and contacts
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Source ClinicalTrials.gov