Trial · NCT00033917
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
NCT00033917, Phase 3, Completed, Yale University; results first posted 2013-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial. Trials, record NCT00033917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
- NCT number
- NCT00033917
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 630 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Intraventricular Hemorrhage (IVH), Bleeding in the Brain, Prematurity, Very Low Birth Weight Infants
- Interventions
- indomethacin, placebo
- First posted
- 2002-04-15
- Last updated
- 2013-03-28
- Results first posted
- 2013-03-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IVH at 5 Postnatal Days | at 5 days | Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age |
| Secondary | Language Outcome | at 8 years | Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language. There are no subscales to the PPVT. The measurement unit is points on a scale. A score \< 70 indicates severely abnormal language function. |
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 | IVH at 5 Postnatal Days | at 5 days | All subjects had negative cranial ultrasounds with no evidence for IVH at 6 - 12 postnatal hours | IVH | NUMBER |
| SECONDARY | Language Outcome | at 8 years | Three hundred twenty eight subjects were available at age 8 years. They were tested with the PPVT. | participants with PPVT score < 70 | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| IVH at 5 Postnatal Days | Indomethacin | 25 | IVH | ||
| IVH at 5 Postnatal Days | Placebo | 40 | IVH | ||
| Language Outcome | Indomethacin - no IVH | 12 | participants with PPVT score < 70 | ||
| Language Outcome | Indomethacin - IVH | 5 | participants with PPVT score < 70 | ||
| Language Outcome | Placebo - no IVH | 24 | participants with PPVT score < 70 | ||
| Language Outcome | Placebo - IVH | 7 | participants with PPVT score < 70 |
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 | IVH Negative Indomethacin | 209 | |
| Overall Study | STARTED | IVH Negative Placebo | 222 | |
| Overall Study | COMPLETED | IVH Negative Indomethacin | 209 | |
| Overall Study | COMPLETED | IVH Negative Placebo | 222 | |
| Overall Study | NOT COMPLETED | IVH Negative Indomethacin | 0 | |
| Overall Study | NOT COMPLETED | IVH Negative Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| other | necrotizing enterocolitis | Gastrointestinal disorders | IVH Negative Indomethacin | 2 | 209 | 2 |
| other | necrotizing enterocolitis | Gastrointestinal disorders | IVH Negative Placebo | 0 | 222 | 0 |
| other | decreased urine output | Renal and urinary disorders | IVH Negative Indomethacin | 19 | 209 | 19 |
| other | decreased urine output | Renal and urinary disorders | IVH Negative Placebo | 10 | 222 | 10 |
| other | creatinine > 1.8 mg/dL | Renal and urinary disorders | IVH Negative Indomethacin | 5 | 209 | 5 |
| other | creatinine > 1.8 mg/dL | Renal and urinary disorders | IVH Negative Placebo | 5 | 222 | 5 |
| other | excessive bleeding | Blood and lymphatic system disorders | IVH Negative Indomethacin | 9 | 209 | 9 |
| other | excessive bleeding | Blood and lymphatic system disorders | IVH Negative Placebo | 10 | 222 | 10 |
| other | platelets < 50,000 | Blood and lymphatic system disorders | IVH Negative Indomethacin | 2 | 209 | 2 |
| other | platelets < 50,000 | Blood and lymphatic system disorders | IVH Negative Placebo | 4 | 222 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IVH Negative Indomethacin | ||
| Total, all-cause mortality | IVH Negative Placebo | ||
| Total, other adverse events | IVH Negative Indomethacin | 19 | 209 |
| Total, other adverse events | IVH Negative Placebo | 12 | 222 |
| Total, serious adverse events | IVH Negative Indomethacin | 0 | 208 |
| Total, serious adverse events | IVH Negative Placebo | 0 | 222 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS027116 | Multicenter Randomized Indomethacin IVH Prevention Trial | MENT, LAURA R. | YALE UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 1989 to 2009 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IVH Negative Indomethacin vs IVH Negative Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Vocabulary Test | Secondary outcome |
Source ConductCognition
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/NCT00033917
GET https://conductscience.org/api/trials/v1/NCT00033917/registered