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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Justine's Hospital
• Collaborator: Rennes University Hospital
• Treatments: Ibuprofen; Vaccines

Criteria

Inclusion Criteria:

• preterm infants less than 32 weeks of gestational age

• Postnatal age more than 7 weeks

• Informed parental consent

Exclusion Criteria:

• anomalies in cardiac conduction

• congenital malformations

• severe intraventricular haemorrhage (grade 3 or 4) or with periventricular leukomalacia