Caffeine Use in the Management of Preterm Infants
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 9 months
Healthy Volunteers: f
View:
⁃ • 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).
Locations
United States
California
UC Irvine Medical Center
RECRUITING
Orange
Contact Information
Primary
Rosie Magallon
rmagallo@hs.uci.edu
714-509-6082
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Caffeine Group
Infants randomized to receive caffeine will continue to receive caffeine at standard of care maintenance dose of 10-15 mg/kg/day given every 24 hours. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth.
Placebo_comparator: Placebo Group
Infants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth.
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine