About this trial
The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing. It will also look at whether caffeine helps these infants get healthy enough to leave the hospital sooner.
The main questions the researchers aim to answer are:
Can the investigators successfully recruit and keep enough participants in the study? Do the medical teams follow the study drug instructions correctly? Does caffeine reduce the total time infants spend in the Neonatal Intensive Care Unit (NICU)? Researchers will compare caffeine to a placebo (a look-alike substance with no active medicine) to see if caffeine is a helpful treatment for babies born between 28 and 34 weeks of gestation who are using a breathing machine or oxygen.
Participants will:
Be randomly assigned to receive either caffeine or a placebo through an IV or a feeding tube.
Receive the study treatment once a day as long as they require respiratory support (and for 24 hours after they stop).
Be monitored by the research team for clinical outcomes like feeding progress, breathing stability, and growth until they are discharged from the hospital.
Eligibility criteria
Qualifiers
Infant born at a gestational age between 28+0 and 34+6 weeks.
Admitted to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of life.
Requiring either invasive respiratory support (mechanical ventilation) or non-invasive respiratory support (e.g., CPAP, High Flow Nasal Cannula) within the first 72 hours of life.
Informed consent obtained from parent(s) or legal guardian(s).
Disqualifiers
Presence of dysmorphic features or major congenital malformations that adversely affect life expectancy.
Known or strongly suspected cyanotic heart disease.
Infants born at <28 weeks' gestational age (due to high risk of apnea requiring routine caffeine).
Late preterm infants born at ≥35+0 weeks' gestational age (due to short NICU stay not allowing for a safe caffeine-free period before discharge).
Trial design
Treatments tested in this trial
- Caffeine
- Placebo