drugset / Trial / NCT02726178

Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants

NCT02726178 ↗

RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2010-02
Primary completion
2011-03
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Advil® Pediatric drops for infants Unknown 5 mg/kg —