Phase 2 N=56 Randomized Quadruple-blind Other

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

Complication Due to Immunization

Bottom Line

View on ClinicalTrials.gov: NCT02726178 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses' Surveillance) Following the First Dose of Pentavalent Vaccine in Preterm Infants Born < 32 Weeks Gestation After Administration of Ibuprofen. — 0.1; 5.4 events/patient/24hours

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Advil® Pediatric drops for infants (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: St. Justine's Hospital
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses' Surveillance) Following the First Dose of Pentavalent Vaccine in Preterm Infants Born < 32 Weeks Gestation After Administration of Ibuprofen.	0.1; 5.4	—
SECONDARY The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization.	-10; -8	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02726178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.