Trial · NCT00955487
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
NCT00955487, Phase 2, Completed, University of Colorado, Denver; results first posted 2017-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns. Trials, record NCT00955487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00955487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
- NCT number
- NCT00955487
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Inhaled Nitric Oxide (iNO), Nitrogen (placebo)
- First posted
- 2009-08-10
- Last updated
- 2017-06-15
- Results first posted
- 2017-05-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Week 36 or earlier, if participants are discharged from the hospital | Number of participants that developed bronchopulmonary dysplasia and/or that died |
| Primary | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | Randomization to discharge | Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams) |
| Secondary | Severity of Bronchopulmonary Dysplasia (BPD) | 36 weeks corrected gestational age | Assessment of the severity of BPD as defined by the oxygen reduction test |
| Secondary | Need for Mechanical Ventilation | Anytime after randomization up to 36 weeks corrected gestational age | Number of participants who required endotracheal intubation and mechanical ventilation |
| Secondary | Total Ventilation Days | After randomization up until hospital discharge | Of those participants who required mechanical ventilation, the total number of days receiving ventilation |
| Secondary | Necrotizing Enterocolitis (NEC) | After randomization through hospital discharge | Number of participants diagnosed with necrotizing enterocolitis |
| Secondary | Symptomatic PDA Requiring Medical Treatment | From randomization until discharge | Number of participants with a symptomatic PDA that required medical treatment |
| Secondary | Symptomatic PDA Requiring Surgical Ligation | Randomization through discharge | Number of participants with symptomatic PDA that required surgical ligation |
| Secondary | Threshold Retinopathy of Prematurity (ROP) | Randomization to discharge | Threshold ROP defined as requiring interventional therapy |
| Secondary | Severe Intracranial Hemorrhage | Randomization to discharge | Number of participants that developed severe intracranial hemorrhage (grade 3-4) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Week 36 or earlier, if participants are discharged from the hospital | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | Randomization to discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Bronchopulmonary Dysplasia (BPD) | 36 weeks corrected gestational age | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Need for Mechanical Ventilation | Anytime after randomization up to 36 weeks corrected gestational age | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Ventilation Days | After randomization up until hospital discharge | Days | MEAN | |
| SECONDARY | Necrotizing Enterocolitis (NEC) | After randomization through hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Symptomatic PDA Requiring Medical Treatment | From randomization until discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Symptomatic PDA Requiring Surgical Ligation | Randomization through discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Threshold Retinopathy of Prematurity (ROP) | Randomization to discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severe Intracranial Hemorrhage | Randomization to discharge | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Inhaled Nitric Oxide (iNO) | Death | 1 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Placebo (Nitrogen) | Death | 2 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Inhaled Nitric Oxide (iNO) | Bronchopulmonary Dysplasia (BPD) | 24 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Placebo (Nitrogen) | Bronchopulmonary Dysplasia (BPD) | 25 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Inhaled Nitric Oxide (iNO) | Death/BPD | 25 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Placebo (Nitrogen) | Death/BPD | 26 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Inhaled Nitric Oxide (iNO) | No Death or BPD | 9 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Placebo (Nitrogen) | No Death or BPD | 12 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | 500-749g Inhaled Nitric Oxide (iNO) | Death | 0 | Participants | |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | 500-749g Placebo (Nitrogen) | Death | 2 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 500-749g Inhaled Nitric Oxide (iNO) | 10 | |
| Overall Study | STARTED | 500-749g Placebo (Nitrogen) | 9 | |
| Overall Study | STARTED | 750-999g Inhaled Nitric Oxide (iNO) | 17 | |
| Overall Study | STARTED | 750-999g Placebo (Nitrogen) | 21 | |
| Overall Study | STARTED | 1000-1250g Inhaled Nitric Oxide (iNO) | 32 | |
| Overall Study | STARTED | 1000-1250g Placebo (Nitrogen) | 35 | |
| Overall Study | COMPLETED | 500-749g Inhaled Nitric Oxide (iNO) | 10 | |
| Overall Study | COMPLETED | 500-749g Placebo (Nitrogen) | 9 | |
| Overall Study | COMPLETED | 750-999g Inhaled Nitric Oxide (iNO) | 17 | |
| Overall Study | COMPLETED | 750-999g Placebo (Nitrogen) | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse 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 | Necrotizing enterocolitis | Gastrointestinal disorders | Inhaled Nitric Oxide (iNO) | 5 | 59 | 5 |
| serious | Necrotizing enterocolitis | Gastrointestinal disorders | Placebo (Nitrogen) | 10 | 65 | 10 |
| serious | Symptomatic PDA | Cardiac disorders | Inhaled Nitric Oxide (iNO) | 1 | 59 | 1 |
| serious | Symptomatic PDA | Cardiac disorders | Placebo (Nitrogen) | 2 | 65 | 2 |
| serious | Symptomatic PDA | Cardiac disorders | Inhaled Nitric Oxide (iNO) | 3 | 59 | 3 |
| serious | Symptomatic PDA | Cardiac disorders | Placebo (Nitrogen) | 8 | 65 | 8 |
| serious | Threshold ROP | Eye disorders | Inhaled Nitric Oxide (iNO) | 3 | 59 | 3 |
| serious | Threshold ROP | Eye disorders | Placebo (Nitrogen) | 4 | 65 | 4 |
| serious | Severe ICH | Nervous system disorders | Inhaled Nitric Oxide (iNO) | 2 | 59 | 2 |
| serious | Severe ICH | Nervous system disorders | Placebo (Nitrogen) | 4 | 65 | 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 | Inhaled Nitric Oxide (iNO) | 2 | 59 |
| Total, all-cause mortality | Placebo (Nitrogen) | 4 | 65 |
| Total, other adverse events | Inhaled Nitric Oxide (iNO) | 0 | 59 |
| Total, other adverse events | Placebo (Nitrogen) | 0 | 65 |
| Total, serious adverse events | Inhaled Nitric Oxide (iNO) | 27 | 59 |
| Total, serious adverse events | Placebo (Nitrogen) | 42 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25063725 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P50HL084923 | Lung Vascular Disease in Infants and Children: Mechanisms and Treatment | STENMARK, KURT R. | UNIVERSITY OF COLORADO DENVER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2007 to 2012 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Necrotizing Enterocolitis (NEC) | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Threshold Retinopathy of Prematurity (ROP) | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Symptomatic PDA Requiring Surgical Ligation | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Severe Intracranial Hemorrhage | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Sepsis | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): deaths from any cause | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): Symptomatic PDA Requiring Medical Treatment | Trial comparisons |
| Inhaled Nitric Oxide (iNO) vs Placebo (Nitrogen): 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/NCT00955487
GET https://conductscience.org/api/trials/v1/NCT00955487/results?page=2