Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support (NCT07456670) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support
Canada62 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range
0 Days – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment/Eligibility Proportion
Timeframe: Through study completion, up to 24 months
2
Treatment Adherence Proportion
Timeframe: From randomization until 24 hours after weaning from respiratory support
3
Retention Proportion
Timeframe: Through study completion, up to 24 months