Trial · NCT00515281
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
NCT00515281, Phase 2, Phase 3, Terminated, University of Chicago; results first posted 2024-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhaled Nitric Oxide and Neuroprotection in Premature Infants. Trials, record NCT00515281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00515281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Nitric Oxide and Neuroprotection in Premature Infants
- NCT number
- NCT00515281
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 273 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Prematurity, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Interventions
- inhaled nitric oxide, oxygen
- First posted
- 2007-08-13
- Last updated
- 2024-10-17
- Results first posted
- 2024-10-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neurodevelopment | Two years | |
| Primary | Bronchopulmonary Dysplasia (BPD) or Death | 36 weeks of age corrected (BPD) or before discharge (death) | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge |
| Secondary | Death | through discharge (up to 400 days) | Death before discharge |
| Secondary | Bronchopulmonary Dysplasia | 36 weeks of age corrected | Need for respiratory support at 36 weeks post-menstrual age (PMA), either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90% |
| Secondary | Supplemental Oxygen Use | 40 weeks PMA | |
| Secondary | BPD or Death in Infants Weighing < 750g | 36 weeks of age corrected (BPD) or before discharge (death) | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge among infants \< 750g |
| Secondary | BPD or Death in Infants Weighing 750-999g | 36 weeks of age corrected (BPD) or before discharge (death) | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge among infants 750-999g |
| Secondary | BPD or Death in Black Infants | 36 weeks of age corrected (BPD) or before discharge (death) | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations \>90%, or death before discharge among Black infants |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neurodevelopment | Two years | Data were not collected (due to funding cuts). | ||
| PRIMARY | Bronchopulmonary Dysplasia (BPD) or Death | 36 weeks of age corrected (BPD) or before discharge (death) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death | through discharge (up to 400 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Bronchopulmonary Dysplasia | 36 weeks of age corrected | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Supplemental Oxygen Use | 40 weeks PMA | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | BPD or Death in Infants Weighing < 750g | 36 weeks of age corrected (BPD) or before discharge (death) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | BPD or Death in Infants Weighing 750-999g | 36 weeks of age corrected (BPD) or before discharge (death) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | BPD or Death in Black Infants | 36 weeks of age corrected (BPD) or before discharge (death) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bronchopulmonary Dysplasia (BPD) or Death | INO Control (Short iNO) | 65 | Participants | ||
| Bronchopulmonary Dysplasia (BPD) or Death | INO Treatment (Long iNO) | 83 | Participants | ||
| Death | INO Control (Short iNO) | 19 | Participants | ||
| Death | INO Treatment (Long iNO) | 13 | Participants | ||
| Bronchopulmonary Dysplasia | INO Control (Short iNO) | 51 | Participants | ||
| Bronchopulmonary Dysplasia | INO Treatment (Long iNO) | 71 | Participants | ||
| Supplemental Oxygen Use | INO Control (Short iNO) | 30 | Participants | ||
| Supplemental Oxygen Use | INO Treatment (Long iNO) | 28 | Participants | ||
| BPD or Death in Infants Weighing < 750g | INO Control (Short iNO) | 36 | Participants | ||
| BPD or Death in Infants Weighing < 750g | INO Treatment (Long iNO) | 37 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INO Control (Short iNO) | 138 | |
| Overall Study | STARTED | INO Treatment (Long iNO) | 135 | |
| Overall Study | COMPLETED | INO Control (Short iNO) | 138 | |
| Overall Study | COMPLETED | INO Treatment (Long iNO) | 135 | |
| Overall Study | NOT COMPLETED | INO Control (Short iNO) | 0 | |
| Overall Study | NOT COMPLETED | INO Treatment (Long iNO) | 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 |
|---|---|---|---|---|---|---|
| serious | Severe IVH/PVL | Vascular disorders | INO Control (Short iNO) | 13 | 138 | |
| serious | Severe IVH/PVL | Vascular disorders | INO Treatment (Long iNO) | 16 | 135 | |
| serious | Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | INO Control (Short iNO) | 2 | 138 | |
| serious | Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | INO Treatment (Long iNO) | 5 | 135 | |
| serious | Pneumorthorax | Respiratory, thoracic and mediastinal disorders | INO Control (Short iNO) | 13 | 138 | |
| serious | Pneumorthorax | Respiratory, thoracic and mediastinal disorders | INO Treatment (Long iNO) | 10 | 135 | |
| serious | Pulmonary interstitial emphysema (PIE) | Respiratory, thoracic and mediastinal disorders | INO Control (Short iNO) | 19 | 138 | |
| serious | Pulmonary interstitial emphysema (PIE) | Respiratory, thoracic and mediastinal disorders | INO Treatment (Long iNO) | 26 | 135 | |
| serious | Symptomatic patent ductus arteriosis (PDA) | Cardiac disorders | INO Control (Short iNO) | 45 | 138 | |
| serious | Symptomatic patent ductus arteriosis (PDA) | Cardiac disorders | INO Treatment (Long iNO) | 41 | 135 |
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 | INO Control (Short iNO) | 19 | 138 |
| Total, all-cause mortality | INO Treatment (Long iNO) | 13 | 135 |
| Total, other adverse events | INO Control (Short iNO) | 0 | 0 |
| Total, other adverse events | INO Treatment (Long iNO) | 0 | 0 |
| Total, serious adverse events | INO Control (Short iNO) | 53 | 138 |
| Total, serious adverse events | INO Treatment (Long iNO) | 61 | 135 |
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| INO Control (Short iNO) vs INO Treatment (Long iNO): Supplemental Oxygen Use | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): Death | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): BPD or Death in Infants Weighing < 750g | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): deaths from any cause | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): BPD or Death in Black Infants | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): BPD or Death in Infants Weighing 750-999g | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): Bronchopulmonary Dysplasia (BPD) or Death | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): Bronchopulmonary Dysplasia | Trial comparisons |
| INO Control (Short iNO) vs INO Treatment (Long iNO): 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/NCT00515281
GET https://conductscience.org/api/trials/v1/NCT00515281/registered