Trial · NCT02726178
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
NCT02726178, Phase 2, Completed, St. Justine's Hospital; results first posted 2017-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants. Trials, record NCT02726178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02726178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
- NCT number
- NCT02726178
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- St. Justine's Hospital
- Conditions
- Complication Due to Immunization
- Interventions
- Advil® Pediatric drops for infants, Placebo
- First posted
- 2016-04-01
- Last updated
- 2018-05-17
- Results first posted
- 2017-06-05
- Limitations and caveats
- 1-the small number of patient recruted
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 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 | The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization. | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization | events/patient/24hours | MEAN | |
| SECONDARY | The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization. | 72 h | msec | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Advil® Pediatric Drops for Infants | 0.1 | Standard Deviation 8 | events/patient/24hours | |
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. | Control | 5.4 | Standard Deviation 10 | events/patient/24hours | |
| The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization. | Advil® Pediatric Drops for Infants | -10 | Standard Deviation 36 | msec | |
| The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization. | Control | -8 | Standard Deviation 28 | msec |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Advil® Pediatric Drops for Infants | 28 | |
| Overall Study | STARTED | Control | 28 | |
| Overall Study | COMPLETED | Advil® Pediatric Drops for Infants | 28 | |
| Overall Study | COMPLETED | Control | 28 | |
| Overall Study | NOT COMPLETED | Advil® Pediatric Drops for Infants | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Advil® Pediatric Drops for Infants | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Advil® Pediatric Drops for Infants | 0 | 28 |
| Total, other adverse events | Control | 0 | 28 |
| Total, serious adverse events | Advil® Pediatric Drops for Infants | 0 | 28 |
| Total, serious adverse events | Control | 0 | 28 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Advil® Pediatric Drops for Infants vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02726178
GET https://conductscience.org/api/trials/v1/NCT02726178/registered