CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Caffeinedrug
Likely dose
Caffeine 20mg/kgfrom 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/NCT01783561
NCT01783561Phase 4Completed
CompareCT.gov

Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Sharp HealthCare·interventional·Posted Feb 5, 2013·Updated Dec 11, 2018

In Brief

A Phase 4 clinical trial evaluating Caffeine for Caffeine. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

Study Details

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

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2013
Enrollment StartOct 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.4 years ago

Interventions

Caffeinedrug

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.