Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support

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.

NCT Number	NCT07456670
Lead Sponsor	Queen's University
Conditions	Preterm Birth, Caffeine, Neonatal Outcomes
Enrollment	62 participants
Start Date	2026-04-01
Primary Completion	2028-03-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-10