Trial · NCT01075178
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
NCT01075178, Completed, Abbott; results first posted 2011-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease. Trials, record NCT01075178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01075178
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
- NCT number
- NCT01075178
- Status
- Completed
- Enrollment
- 2,036 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Severe Respiratory Syncytial Virus Infection
- First posted
- 2010-02-25
- Last updated
- 2011-03-23
- Results first posted
- 2011-02-24
- Limitations and caveats
Only serious adverse events of infection and arrhythmia as well as deaths were collected in this study. The criterion for non-inferiority was not met for death, most likely because the reported mortality rates were lower than expected in both groups.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | 8-month chart review period in CASES and CONTROLS | The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event |
| Primary | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | 8-month chart review period in CASES and CONTROLS | The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event |
| Primary | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | 8-month chart review period in CASES and CONTROLS | The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event |
| Primary | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | 8-month chart review period in CASES and CONTROLS | The number of subjects who died |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | 8-month chart review period in CASES and CONTROLS | The population analyzed included the full analysis set. | participants | NUMBER |
| PRIMARY | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | 8-month chart review period in CASES and CONTROLS | The population analyzed included the full analysis set. | participants | NUMBER |
| PRIMARY | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | 8-month chart review period in CASES and CONTROLS | The population analyzed included the full analysis set. | participants | NUMBER |
| PRIMARY | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | 8-month chart review period in CASES and CONTROLS | The population analyzed included the full analysis set. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | Palivizumab-treated Subjects (CASES) | 303 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | Non-palivizumab-treated Subjects (CONTROLS) | 349 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | Palivizumab-treated Subjects (CASES) | 281 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | Non-palivizumab-treated Subjects (CONTROLS) | 329 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | Palivizumab-treated Subjects (CASES) | 41 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | Non-palivizumab-treated Subjects (CONTROLS) | 39 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | Palivizumab-treated Subjects (CASES) | 9 | participants | ||
| Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | Non-palivizumab-treated Subjects (CONTROLS) | 10 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Subject Matching | STARTED | Palivizumab-treated Subjects (CASES) | 1,148 | |
| Subject Matching | STARTED | Non-palivizumab-treated Subjects (CONTROLS) | 1,421 | |
| Subject Matching | COMPLETED | Palivizumab-treated Subjects (CASES) | 1,018 | |
| Subject Matching | COMPLETED | Non-palivizumab-treated Subjects (CONTROLS) | 1,018 | |
| Subject Matching | NOT COMPLETED | Palivizumab-treated Subjects (CASES) | 130 | |
| Subject Matching | NOT COMPLETED | Non-palivizumab-treated Subjects (CONTROLS) | 403 | |
| Subject Chart Review | STARTED | Palivizumab-treated Subjects (CASES) | 1,018 | |
| Subject Chart Review | STARTED | Non-palivizumab-treated Subjects (CONTROLS) | 1,018 | |
| Subject Chart Review | COMPLETED | Palivizumab-treated Subjects (CASES) | 1,009 | |
| Subject Chart Review | COMPLETED | Non-palivizumab-treated Subjects (CONTROLS) | 1,009 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Arrhythmia | Cardiac disorders | Palivizumab-treated Subjects (CASES) | 4 | 1,009 | |
| serious | Arrhythmia | Cardiac disorders | Non-palivizumab-treated Subjects (CONTROLS) | 8 | 1,009 | |
| serious | Arrhythmia supraventricular | Cardiac disorders | Palivizumab-treated Subjects (CASES) | 1 | 1,009 | |
| serious | Arrhythmia supraventricular | Cardiac disorders | Non-palivizumab-treated Subjects (CONTROLS) | 0 | 1,009 | |
| serious | Atrial fibrillation | Cardiac disorders | Palivizumab-treated Subjects (CASES) | 0 | 1,009 | |
| serious | Atrial fibrillation | Cardiac disorders | Non-palivizumab-treated Subjects (CONTROLS) | 1 | 1,009 | |
| serious | Atrial flutter | Cardiac disorders | Palivizumab-treated Subjects (CASES) | 1 | 1,009 | |
| serious | Atrial flutter | Cardiac disorders | Non-palivizumab-treated Subjects (CONTROLS) | 0 | 1,009 | |
| serious | Atrial tachycardia | Cardiac disorders | Palivizumab-treated Subjects (CASES) | 1 | 1,009 | |
| serious | Atrial tachycardia | Cardiac disorders | Non-palivizumab-treated Subjects (CONTROLS) | 2 | 1,009 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palivizumab-treated Subjects (CASES) | ||
| Total, all-cause mortality | Non-palivizumab-treated Subjects (CONTROLS) | ||
| Total, other adverse events | Palivizumab-treated Subjects (CASES) | 0 | 0 |
| Total, other adverse events | Non-palivizumab-treated Subjects (CONTROLS) | 0 | 0 |
| Total, serious adverse events | Palivizumab-treated Subjects (CASES) | 303 | 1,009 |
| Total, serious adverse events | Non-palivizumab-treated Subjects (CONTROLS) | 349 | 1,009 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. | Trial comparisons |
| Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | Trial comparisons |
| Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia | Trial comparisons |
Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death | Trial comparisons |
| Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): serious adverse events | 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/NCT01075178
GET https://conductscience.org/api/trials/v1/NCT01075178/events?page=2