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

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ClinicalTrials.gov Identifier: NCT02726178
Recruitment Status : Completed
First Posted : April 1, 2016
Results First Posted : June 5, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Rennes University Hospital
Information provided by (Responsible Party):
Anne-Monique NUYT, St. Justine's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Complication Due to Immunization Drug: Advil® Pediatric drops for infants Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Advil® Pediatric drops for infants

Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.

The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.

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
Other Name: Oral Ibuprofen

Placebo Comparator: Control

Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.

The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.

Drug: Placebo
Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
Other Name: Oral placebo:sodium stearate 0.25g+lactose 0.5g+15 ml syrup




Primary Outcome Measures :
  1. 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. [ Time Frame: the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization ]
    Immunization with the pentavalent vaccine Diphtheria-Tetanus-Acellular pertussis-Inactivated poliomyelitis-Haemophilus influenzae type b (DTPa-IPV-Hib) at two months of age is known to be associated with cardio-respiratory events (CRE), in 11 to 47% of preterm infants.It is considered that the immature brainstem respiratory control of preterms make them more vulnerable to the inflammatory reaction caused by immunization. We hypothesized that post-immunization CRE are correlated with inflammatory reaction. The primary objective was to examine the impact of endogenous PG inhibition on the occurrence of CRE following the first dose of pentavalent vaccine in preterm infants born < 32 weeks gestation. Total CRE was expressed as the average number of events (desaturation + apneas + bradycardia) / 24 hours. Δ Total CRE / patient / 24 hours was defined as the difference between the average number of events / 24 hours observed before vs. after immunization for each patient.


Secondary Outcome Measures :
  1. The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization. [ Time Frame: 72 h ]
    The secondary objective was to identify predictive factors of occurrence of CRE in preterm infants after immunization through the analysis of their HRV. Two annotated polysomnographies were performed for all patients with an AURA PSG GRASS ambulatory and wireless system. Each polysomnography had a duration of 2.5 hours: the first was conducted on enrolment (the day before immunization), and the second was conducted 18 to 24 hours after immunization : we compared the mean of the datas of polysomnographies after to those before immunization.



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Ages Eligible for Study:   7 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726178


Sponsors and Collaborators
St. Justine's Hospital
Rennes University Hospital
Investigators
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Principal Investigator: Anne Monique Nuyt, MD Ste-Justine's hospital

Additional Information:
Publications:
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Responsible Party: Anne-Monique NUYT, Neonatalogist, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02726178     History of Changes
Other Study ID Numbers: 2917
First Posted: April 1, 2016    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: May 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anne-Monique NUYT, St. Justine's Hospital:
Apnea
bradycardia
immunization
inflammation
preterms

Additional relevant MeSH terms:
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Ibuprofen
Vaccines
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors