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Methylxanthine

Caffeine Group for Primary Apnea of Prematurity

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to full feeds

Secondary outcome measures

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

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,923,003 Total Patients Enrolled

Cherry Uy, MDPrincipal InvestigatorUC Irvine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals younger than 18 years old participate in this medical study?

"To be considered for this study, individuals aged between 1 day and 40 weeks are eligible. Notably, there are a total of 196 trials available for those under 18 years old and 85 studies catered towards participants over the age of 65."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"To qualify for enrollment in this research study, individuals must be diagnosed with primary apnea of prematurity and fall within the age range of 1 day to 40 weeks. The trial aims to recruit approximately 40 eligible participants."

Answered by AI

What is the current number of participants enrolled in this clinical study?

"Indeed, the information on clinicaltrials.gov reveals that this clinical investigation is currently seeking volunteers. The trial was initially listed on February 22nd, 2024 and most recently revised on March 21st, 2024. It aims to recruit a total of 40 participants at a single site."

Answered by AI

Does the FDA acknowledge Caffeine Group as a sanctioned product?

"In accordance with our assessment at Power, the safety rating for Caffeine Group stands at 2. This is due to its Phase 2 trial status which implies existing safety data but lacks evidence of efficacy."

Answered by AI

Are researchers currently enrolling participants for this study?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively seeking candidates. The trial was first posted on February 22nd, 2024 and last updated on March 21st of the same year. The study aims to enroll 40 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Caffeine Use in the Management of Preterm Infants

Cherry Uy 2024. "Caffeine Use in the Management of Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06327152.

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