Caffeine Optimization for Oxygen Saturation in Premature Infants
This study is looking at whether a higher dose of caffeine citrate can help extremely premature infants (born before 28 weeks of pregnancy) breathe better and reduce health problems. These babies often have trouble breathing because their lungs are not fully developed. Caffeine is commonly used to help with breathing, but the best and safest dose isn't fully known. This study will compare a higher dose of caffeine citrate (10 mg/kg/day) to the standard dose to see if it improves how much oxygen babies get (measured by Oxygen Saturation Index or OSI). We are looking for 40 infants, aged 0 days to 27 weeks, who were born at URMC with a gestational age of 22 to 27 weeks, or those born at 28 weeks or more but weighing less than 1000 grams. The current status of the study is unclear.
- Study design
- This is an interventional study planning to enroll 40 extremely premature infants. It will compare a high dose of caffeine citrate to a standard dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for their average Oxygen Saturation Index for the first 56 days, and for total duration of respiratory support and incidence of severe bronchopulmonary dysplasia (BPD) up to 1 year.
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Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Average Oxygen Saturation Index (OSI) per Patient Over First 56 DaysFrom 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 SupportFrom 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)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)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 StayBirth to 1 year
Total number of days each infant remains in the NICU from birth until discharge.
- Total Number of Infant DeathsFrom Randomization to 1 year
Number of infants who die before NICU discharge.
- Total Test of Infant Motor Performance (TIMP) Score Prior to DischargePrior 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)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)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)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)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)From Randomization to 1 year
Number of days with blood pressure \>95th percentile for gestational age.
- Total Time to Full Enteral FeedsFrom Randomization to 1 year
Days from birth until the infant reaches 120 mL/kg/day enteral nutrition.
- Total Number of NPO Periods >24 HoursFrom Randomization through NICU Discharge
Number of times infant is NPO (nothing by mouth) for more than 24 hours.
- Total Incidence of Necrotizing Enterocolitis (NEC)From Randomization to 1 year
Number of infants diagnosed with NEC (Bell's stage II or higher).
- Total Incidence of Spontaneous Intestinal Perforation (SIP)From Randomization to 1 year
Number of infants with radiographically or surgically confirmed SIP.