CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Caffeine citratedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00809055
NCT00809055Phase 4Completed

Magnetic Resonance Imaging and Neurodevelopmental Outcomes in Preterm Infants Following Administration of High-Dose Caffeine - A Pilot Study

Washington University School of Medicine·interventional·Posted Dec 16, 2008·Updated Feb 24, 2016

In Brief

A Phase 4 clinical trial evaluating Caffeine citrate for Apnea of Prematurity and 2 related conditions. Completed, enrolled 74 participants across 1 site.

Detailed Summary

Over the last 30 years the survival rates for babies born prematurely have improved greatly with research. As these babies grow up, we have found that many of the premature babies have learning and movement problems. The purpose of this research is to learn why premature infants are at risk for learning disabilities and movement problems later in childhood and whether this is changed by caffeine therapy. Caffeine is often used in premature babies to help them to breathe on their own. Nearly all babies born before 30 weeks gestation receive caffeine while they are in the neonatal intensive care unit (NICU). Scientists have shown that caffeine therapy given to premature babies reduces their disabilities. We will use brain monitoring, including electro-encephalogram (EEG) and magnetic resonance imaging (MRI) to understand how the brain of a premature baby develops and whether caffeine in high doses enhances protection of the developing brain. Just as we monitor the heart and lungs to improve our care of premature babies, we wish to monitor the brain so that we can understand how to improve our care for the brain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.5 years ago

Interventions

Caffeine citratedrug

Caffeine to be administered as outlined to compare efficacy of different dosages.