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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Complication Due to Immunization
Interventions Drug: Advil® Pediatric drops for infants
Drug: Placebo
Enrollment 56
Recruitment Details The recruitment process was conducted in the neonatal intensive care unit of Sainte-Justine University Hospital (CHU Sainte-Justine, Montreal, QC, Canada) over a period of fourteen months (February 2010 - March 2011).
Pre-assignment Details A total of 362 preterm infants were screened, 56 completed the study. Of the infants who did not participate in the study, 212 were discharged before the first immunization (92 to home and 120 to level II nurseries), 37 died, 28 were still intubated at the time of enrolment, 14 did not meet the inclusion criteria, and parents refused for 15.
Arm/Group Title Advil® Pediatric Drops for Infants Control
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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.

Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

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.

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

Period Title: Overall Study
Started 28 28
Completed 28 28
Not Completed 0 0
Arm/Group Title Advil® Pediatric Drops for Infants Control Total
Hide Arm/Group Description

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.

Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 28 participants 28 participants 56 participants
27.8  (1.8) 27.2  (2) 27.5  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
14
  50.0%
15
  53.6%
29
  51.8%
Male
14
  50.0%
13
  46.4%
27
  48.2%
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Advil® Pediatric Drops for Infants Control
Hide Arm/Group Description:

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.

Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

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.

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

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: events/patient/24hours
0.1  (8) 5.4  (10)
2.Secondary Outcome
Title The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization.
Hide Description 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.
Time Frame 72 h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Advil® Pediatric Drops for Infants Control
Hide Arm/Group Description:

Two annotated polysomnographies were performed for all patients:

The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.

The second was conducted 18 to 24 hours after immunization.

We compared the data of polysomnographies after to those before immunization.

Polysomnography : an AURA PSG GRASS ambulatory and wireless system.

Two annotated polysomnographies were performed for all patients:

The first annotated polysomnography was conducted the day before immunization and had a duration of 2.5 hours.

The second was conducted 18 to 24 hours after immunization.

We compared the data of polysomnographies after to those before immunization.

Polysomnography : an AURA PSG GRASS ambulatory and wireless system.

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: msec
-10  (36) -8  (28)
Time Frame 2 days after the first immunization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Advil® Pediatric Drops for Infants Control
Hide Arm/Group Description

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.

Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants

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.

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

All-Cause Mortality
Advil® Pediatric Drops for Infants Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Advil® Pediatric Drops for Infants Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Advil® Pediatric Drops for Infants Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Anne Monique Nuyt
Organization: Sainte Justine university hospital center
Phone: 514 3454931 ext 3971
Responsible Party: Anne-Monique NUYT, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02726178     History of Changes
Other Study ID Numbers: 2917
First Submitted: October 20, 2015
First Posted: April 1, 2016
Results First Submitted: April 27, 2016
Results First Posted: June 5, 2017
Last Update Posted: May 17, 2018