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

NCT02726178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-05-17

Study results available
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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.

Conditions

  • Complication Due to Immunization

Interventions

DRUG

Advil® Pediatric drops for infants

Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

DRUG

Placebo

Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

Sponsors & Collaborators

  • Rennes University Hospital

    collaborator OTHER

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Anne Monique Nuyt, MD · Ste-Justine's hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726178 on ClinicalTrials.gov