NCT06327152

Caffeine Use in the Management of Preterm Infants

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 1 Week – 40 Weeks
• Healthy volunteers: Not accepted

Summary

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

Detailed description

This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DRUG	Caffeine	Infants randomized to receive caffeine will continue to receive caffeine at the current weight-based dose (which is the standard of care maintenance dose of 10-15 mg/kg/day) given every 24 hours. The weight-based dose calculated using the weight at the time of enrollment will be the weight-based dose used for the duration of the study. 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. The study drug (caffeine) will be administered for a maximum of 4 weeks. The study drug will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The study drug will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.
OTHER	Sterile Water Placebo	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. The placebo will be administered for a maximum of 4 weeks. The placebo will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The placebo will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.

Timeline

• Start date: 2024-02-22
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2024-03-25
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study