Caffeine for Premature Birth

Phase 2

Recruiting

Led By Cherry Uy, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization until discharge, up to 6 weeks

Summary

"This trial will see if giving preterm babies caffeine for a longer time helps them start feeding on their own more quickly."

Who is the study for?

This trial is for preterm infants born at or before 32 weeks, currently on caffeine treatment but ready to stop, and off respiratory support for a week. They should be at least 34 weeks corrected gestation without significant breathing problems in the past 5 days. Infants with neuromuscular issues, critical heart disease, severe brain injury, or who are already advancing in oral feeding protocols cannot participate.

What is being tested?

The study is testing if continuing caffeine therapy longer than usual can help premature babies learn to eat by mouth quicker. Babies will either continue receiving caffeine or get a sterile water placebo to see which method leads to faster full oral feeding.

What are the potential side effects?

Caffeine may cause side effects like increased heart rate, sleep disturbances, jitteriness in some infants. The placebo (sterile water) is not expected to have any side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization until discharge, up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization until discharge, up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until discharge, up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to full feeds

Secondary study objectives

Number of significant cardiopulmonary events

Post menstrual age (PMA) at time of discharge

Time to discharge

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Caffeine GroupActive Control1 Intervention

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.

Group II: Placebo GroupPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out