Trial · NCT00833365
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
NCT00833365, Not applicable, Terminated, University of Utah; results first posted 2016-07-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure. Trials, record NCT00833365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00833365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
- NCT number
- NCT00833365
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Patent Ductus Arteriosus, Prematurity
- Interventions
- Ibuprofen, Ibuprofen
- First posted
- 2009-02-02
- Last updated
- 2016-07-04
- Results first posted
- 2016-07-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of PDA Closures Related to Treatment With Ibuprofen | Within 48 hrs of ibuprofen round | Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant. |
| Secondary | Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration | 1 and 6 hours |
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 | Number of PDA Closures Related to Treatment With Ibuprofen | Within 48 hrs of ibuprofen round | Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis. | closures related to treatment | NUMBER |
| SECONDARY | Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration | 1 and 6 hours | Due to early termination of the study, labs were not analyzed. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of PDA Closures Related to Treatment With Ibuprofen | Early Treatment | 1 | closures related to treatment | ||
| Number of PDA Closures Related to Treatment With Ibuprofen | Late Treatment | 0 | closures related to treatment |
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 Treatment | 9 | |
| Overall Study | STARTED | Late Treatment | 6 | |
| Overall Study | COMPLETED | Early Treatment | 9 | |
| Overall Study | COMPLETED | Late Treatment | 6 | |
| Overall Study | NOT COMPLETED | Early Treatment | 0 | |
| Overall Study | NOT COMPLETED | Late Treatment | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Death | Infections and infestations | Early Treatment | 1 | 9 | |
| serious | Death | Infections and infestations | Late Treatment | 0 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early Treatment | ||
| Total, all-cause mortality | Late Treatment | ||
| Total, other adverse events | Early Treatment | 0 | 9 |
| Total, other adverse events | Late Treatment | 0 | 6 |
| Total, serious adverse events | Early Treatment | 1 | 9 |
| Total, serious adverse events | Late Treatment | 0 | 6 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Early Treatment vs Late Treatment: 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/NCT00833365
GET https://conductscience.org/api/trials/v1/NCT00833365/registered