Overview

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

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
St. Justine's Hospital
Collaborator:
Rennes University Hospital
Treatments:
Ibuprofen
Vaccines