Caffeine Use in the Management of Preterm Infants (NCT06327152) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Caffeine Use in the Management of Preterm Infants
United States80 participantsStarted 2024-02-22
Plain-language summary
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.
Who can participate
Age range
1 Week – 40 Weeks
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:
• Infants born at equal to or less than 32 weeks and 0 days gestational age AND
* Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
* Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
* On caffeine and meet criteria to discontinue caffeine.
* No significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (HR) \< 80 beats per minute (bpm), HR \< 80 bpm with desaturation \< 85% or color change).
Exclusion Criteria:
* Infants with critical congenital heart disease.
* Infants with neuromuscular conditions affecting respiration.
* Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
* Infants with major genetic disorders.
* Infants with anatomic anomalies that will hinder oral feeding.
* Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
* Infants who develop necrotizing enterocolitis after enrollment.
* Failure to obtain consent or declined by parents.
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
Time to full feeds
Timeframe: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks