Caffeine Use in the Management of Preterm Infants (NCT06327152) | Clinical Trial Compass
Active ā 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 range1 Week ā 40 Weeks
SexALL
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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.
What they're measuring
1
Time to full feeds
Timeframe: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks