drugset / Trial / NCT02726178
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
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
Publications
- Background Hoch B, Bernhard M. Central apnoea and endogenous prostaglandins in neonates. Acta Paediatr. 2000 Nov;89(11):1364-8. doi: 10.1080/080352500300002589.
- Background Schulzke S, Heininger U, Lucking-Famira M, Fahnenstich H. Apnoea and bradycardia in preterm infants following immunisation with pentavalent or hexavalent vaccines. Eur J Pediatr. 2005 Jul;164(7):432-5. doi: 10.1007/s00431-005-1674-3. Epub 2005 Apr 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Advil® Pediatric drops for infants | Unknown | 5 mg/kg | — |