CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Advil® Pediatric drops for infants +1 moredrug
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/NCT02726178
NCT02726178Phase 2Completed
CompareCT.gov

Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study

St. Justine's Hospital·interventional·Posted Apr 1, 2016·Updated May 17, 2018

In Brief

A Phase 2 clinical trial evaluating Advil® Pediatric drops for infants and Placebo for Complication Due to Immunization. Completed, enrolled 56 participants.

Detailed Summary

Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE). Methods: Randomized double-blind controlled study of infants born \<32 weeks gestation receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group and a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were assessed before and after immunization. CRE were recorded for 72 hours. Heart rate variability (HRV) was assessed by polysomnography.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplication Due to Immunization
Countries--
CollaboratorsRennes University Hospital

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2016
Enrollment StartFeb 1, 2010
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.3 years ago

Interventions

Advil® Pediatric drops for infantsdrug

Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

Placebodrug

Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants