Caffeine Use in the Management of Preterm Infants

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how caffeine therapy can help preterm infants with a condition called apnea of prematurity, which means they sometimes have trouble breathing. The goal is to see if using caffeine for a longer time can help these infants learn to eat by mouth more quickly. The trial is currently looking for participants who are infants born before 32 weeks of pregnancy but are at least 34 weeks old when they join the study. Eligible infants should have been off breathing support for a couple of days and have been on caffeine, but are ready to stop taking it.

Parents considering this trial should know that their baby will be monitored closely for safety, and they may receive caffeine treatment as part of the study. It’s important to note that some infants will not be eligible to participate, especially those with certain medical conditions that could affect their ability to eat or breathe. This study aims to improve care for preterm infants, and by participating, families can contribute to important research that may help future babies.

Gender

ALL

Eligibility criteria

• 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.