Trial · NCT00802685
Timing of PDA Closure and Respiratory Outcome in Premature Infants
NCT00802685, Not applicable, Terminated, University of Miami; results first posted 2013-11-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Timing of PDA Closure and Respiratory Outcome in Premature Infants. Trials, record NCT00802685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00802685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Timing of PDA Closure and Respiratory Outcome in Premature Infants
- NCT number
- NCT00802685
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 105 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Patent Ductus Arteriosus
- Interventions
- Early ibuprofen, Late ibuprofen expectant group (placebo)
- First posted
- 2008-12-05
- Last updated
- 2014-02-05
- Results first posted
- 2013-11-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days Spent on Supplemental Oxygen During the First 28 Days. | 28 days of life | |
| Secondary | Number of Participants on Oxygen at 36 Weeks Postmenstrual Age | at 36 weeks postmenstrual age |
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 | Days Spent on Supplemental Oxygen During the First 28 Days. | 28 days of life | The number of participants for analysis was determined from all subjects who completed the study intervention at 28 days of age and had complete data on the primary endpoint of oxygen days during the first 28 days. Analysis was done on intention to treat basis. | days | MEDIAN |
| SECONDARY | Number of Participants on Oxygen at 36 Weeks Postmenstrual Age | at 36 weeks postmenstrual age | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Days Spent on Supplemental Oxygen During the First 28 Days. | Early Ibuprofen | 21 | Full Range 7 to 27 | days | |
| Days Spent on Supplemental Oxygen During the First 28 Days. | Late Ibuprofen Expectant Group | 19 | Full Range 5 to 26 | days | |
| Number of Participants on Oxygen at 36 Weeks Postmenstrual Age | Early Ibuprofen | 17 | 15 to 20 | participants | |
| Number of Participants on Oxygen at 36 Weeks Postmenstrual Age | Late Ibuprofen Expectant Group | 16 | 15 to 20 | participants |
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 | Early Ibuprofen | 54 | |
| Overall Study | STARTED | Late Ibuprofen Expectant Group | 51 | |
| Overall Study | COMPLETED | Early Ibuprofen | 54 | |
| Overall Study | COMPLETED | Late Ibuprofen Expectant Group | 51 | |
| Overall Study | NOT COMPLETED | Early Ibuprofen | 0 | |
| Overall Study | NOT COMPLETED | Late Ibuprofen Expectant Group | 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 | Early Ibuprofen | ||
| Total, all-cause mortality | Late Ibuprofen Expectant Group | ||
| Total, other adverse events | Early Ibuprofen | 0 | 54 |
| Total, other adverse events | Late Ibuprofen Expectant Group | 0 | 51 |
| Total, serious adverse events | Early Ibuprofen | 0 | 54 |
| Total, serious adverse events | Late Ibuprofen Expectant Group | 0 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22284563 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Early Ibuprofen vs Late Ibuprofen Expectant Group: Number of Participants on Oxygen at 36 Weeks Postmenstrual Age | Trial comparisons |
| Early Ibuprofen vs Late Ibuprofen Expectant Group: 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/NCT00802685
GET https://conductscience.org/api/trials/v1/NCT00802685/registered