Trial · NCT01467076
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
NCT01467076, Phase 2, Terminated, NICHD Neonatal Research Network; results first posted 2016-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF). Trials, record NCT01467076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
- NCT number
- NCT01467076
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- NICHD Neonatal Research Network
- Conditions
- Prematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
- Interventions
- Aerosolized Normal Saline, Inhaled PGE1
- First posted
- 2011-11-08
- Last updated
- 2019-04-24
- Results first posted
- 2016-12-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study | From study start through 9 months after 75% of the participating sites are enrolling | The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (\>20%) protocol violations. |
| Secondary | Change in Partial Pressure of Oxygen in the Blood (PaO2) | Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol. | Changes in PaO2 based on the arterial blood gases (ABG) measurements obtained after 60 minutes and ABG obtained 4 hours after start of study aerosol. |
| Secondary | Change in Oxygenation Index (OI) | Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol. | Change in OI based on the arterial blood gases (ABG) measurements obtained at 60±15 minutes and ABG obtained 4±2 hours after start of study aerosol. |
| Secondary | Need for Inhaled Nitric Oxide (INO) 72 Hours After INO | Date of first administration of INO to date of final discontinuation of INO | Administration of INO continued after the Infant was on INO for 72 hours |
| Secondary | Duration of iNO Therapy | From date of first administration of INO to date of final discontinuation of INO. | Duration the infant is on INO from initial administration of INO to final discontinuation of INO. |
| Secondary | Death | From birth through status (death, transfer, or discharge). | Deaths prior to discharge home. |
| Secondary | Need for Extracorporeal Membrane Oxygenation (ECMO) | From after discontinuation of study aerosol through status (death, transfer, or discharge). | ECMO provided at the institution for the infant after discontinuation of study aerosol. |
| Secondary | Duration of Mechanical Ventilation | From birth through status (death, transfer or discharge) | Duration the infant is on Mechanical Ventilation from birth through status (death, transfer or discharge) |
| Secondary | Number of Days of Supplemental Oxygen (O2) Used | From birth through status (death, transfer or discharge) | Number of days from birth during which the FiO2 at some point was \> 0.21. |
| Secondary | Length of Hospital Stay | From birth to discharge home | Length of stay in hospital from birth to discharge home. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study | From study start through 9 months after 75% of the participating sites are enrolling | Late preterm \& term infants ≤ 7 days postnatal age undergoing conventional ventilation (CNV) or high frequency oscillatory ventilation (HFOV) for NHRF (including perinatal aspiration syndrome, suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic PPHN or suspected pulmonary hypoplasia) with suboptimal response to INO | participants | NUMBER |
| SECONDARY | Change in Partial Pressure of Oxygen in the Blood (PaO2) | Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol. | To gauge the improvement in PaO2 for each group, the average of the difference between the two PaO2 ABG measurements (measurement at 4±2 hours-measurement at 60±15 minutes after start of study aerosol) and the range(minimum, maximum) of the differences between OI ABG measurements at the two time points within each group are presented here. | mmHg | MEAN |
| SECONDARY | Change in Oxygenation Index (OI) | Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol. | To gauge change in OI for each group we present both the average and the range of the difference between the two OI ABG measurements (measurement at 4±2 hours - measurement at 60±15 minutes after start of study aerosol). A positive difference indicates an increase in OI measurement; a negative difference indicates a decrease in OI measurement. | oxygenation index | MEAN |
| SECONDARY | Need for Inhaled Nitric Oxide (INO) 72 Hours After INO | Date of first administration of INO to date of final discontinuation of INO | Date of final discontinuation of INO was not available for 1 infant in the Control group and 1 infant in the LOW DOSE IPGE1 group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of iNO Therapy | From date of first administration of INO to date of final discontinuation of INO. | The date of final discontinuation of INO was recorded for 2 infants in the control group, 1 infant in the low dose and all 2 infants in the high dose group. | hours | MEAN |
| SECONDARY | Death | From birth through status (death, transfer, or discharge). | All 3 infants in the control group, 2 infant in the Low dose and 2 infants in the High dose IPGE1 groups have status data (death, transfer or discharge). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Need for Extracorporeal Membrane Oxygenation (ECMO) | From after discontinuation of study aerosol through status (death, transfer, or discharge). | All 3 infants in the control group, 2 infant in the Low dose and 2 infants in the High dose IPGE1 groups have data on ECMO use at the institution after discontinuation of study aerosol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Mechanical Ventilation | From birth through status (death, transfer or discharge) | All 3 infants in the aerosolized saline group, and the 2 infants in the lower dose IPGE1 group and high dose IPGE1 Group have the number of days on mechanical ventilation from birth to death, transfer or discharge. | Days | MEAN |
| SECONDARY | Number of Days of Supplemental Oxygen (O2) Used | From birth through status (death, transfer or discharge) | All 3 infants in the aerosolized saline group, and the 2 infants in the lower dose IPGE1 group and high dose IPGE1 Group have the number of days on supplemental oxygen from birth to death, transfer or discharge. | Days | MEAN |
| SECONDARY | Length of Hospital Stay | From birth to discharge home | Two infants in the aerosolized saline group, and 2 infants in the lowd ose IPGE1 group and high dose IPGE1 Group were discharged home/chronic care. | Days | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study | Control | 3 | participants | ||
| Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study | Low Dose IPGE1 | 2 | participants | ||
| Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study | High Dose IPGE1 | 2 | participants | ||
| Change in Partial Pressure of Oxygen in the Blood (PaO2) | Control | 30 | Full Range -1 to 59 | mmHg | |
| Change in Partial Pressure of Oxygen in the Blood (PaO2) | Low Dose IPGE1 | 85 | Full Range 22 to 148 | mmHg | |
| Change in Partial Pressure of Oxygen in the Blood (PaO2) | High Dose IPGE1 | 48 | Full Range -9 to 95 | mmHg | |
| Change in Oxygenation Index (OI) | Control | 4 | Full Range -1 to 9 | oxygenation index | |
| Change in Oxygenation Index (OI) | Low Dose IPGE1 | 14 | Full Range 6 to 21 | oxygenation index | |
| Change in Oxygenation Index (OI) | High Dose IPGE1 | 10 | Full Range -5 to 25 | oxygenation index | |
| Need for Inhaled Nitric Oxide (INO) 72 Hours After INO | Control | 1 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 3 | |
| Overall Study | STARTED | Low Dose IPGE1 | 2 | |
| Overall Study | STARTED | High Dose IPGE1 | 2 | |
| Overall Study | COMPLETED | Control | 2 | |
| Overall Study | COMPLETED | Low Dose IPGE1 | 2 | |
| Overall Study | COMPLETED | High Dose IPGE1 | 2 | |
| Overall Study | NOT COMPLETED | Control | 1 | |
| Overall Study | NOT COMPLETED | Low Dose IPGE1 | 0 | |
| Overall Study | NOT COMPLETED | High Dose IPGE1 | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | Hypotension | Blood and lymphatic system disorders | Control | 1 | 3 | 1 |
| serious | Hypotension | Blood and lymphatic system disorders | Low Dose IPGE1 | 0 | 2 | 0 |
| serious | Hypotension | Blood and lymphatic system disorders | High Dose IPGE1 | 0 | 2 | 0 |
| serious | Arrhythmia | Cardiac disorders | Control | 0 | 3 | 0 |
| serious | Arrhythmia | Cardiac disorders | Low Dose IPGE1 | 0 | 2 | 0 |
| serious | Arrhythmia | Cardiac disorders | High Dose IPGE1 | 0 | 2 | 0 |
| serious | New onset seizures | Nervous system disorders | Control | 0 | 3 | 0 |
| serious | New onset seizures | Nervous system disorders | Low Dose IPGE1 | 0 | 2 | 0 |
| serious | New onset seizures | Nervous system disorders | High Dose IPGE1 | 0 | 2 | 0 |
| serious | New onset bleeding | Blood and lymphatic system disorders | Control | 0 | 3 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | Low Dose IPGE1 | ||
| Total, all-cause mortality | High Dose IPGE1 | ||
| Total, other adverse events | Control | 0 | 3 |
| Total, other adverse events | Low Dose IPGE1 | 0 | 2 |
| Total, other adverse events | High Dose IPGE1 | 0 | 2 |
| Total, serious adverse events | Control | 2 | 3 |
| Total, serious adverse events | Low Dose IPGE1 | 0 | 2 |
| Total, serious adverse events | High Dose IPGE1 | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25496504 | DERIVED |
Source PubMed
Grants12
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 | Source |
|---|---|---|---|---|---|---|
| U10HD036790 | Neonatal Research Network Data Coordinating Center (DCC) | DAS, ABHIK | RESEARCH TRIANGLE INSTITUTE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2008 to 2017 | NIH RePORTER |
| U10HD021385 | Cooperative Multicenter Network of Neontal Intensive Care Units | SHANKARAN, SEETHA | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027880 | NICHD Cooperative Multicenter Neonatal Research Network | VAN MEURS, KRISA PAGE | STANFORD UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027904 | NICHD Cooperative Multicenter Neonatal Research Network | LAPTOOK, ABBOT R | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034216 | Cooperative Multicenter Neonatal Research Network - UAB | CARLO FONT, WALDEMAR A. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD040461 | NICHD Coooperative Multicenter Neonatal Research Network | VAUCHER, YVONNE ELEANOR | UNIVERSITY OF CALIFORNIA, SAN DIEGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040492 | Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network | COTTEN, CHARLES MICHAEL | DUKE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040689 | NICHD Cooperative Multicenter Neonatal Research Network | WYCKOFF, MYRA HELEN | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD053109 | NICHD Cooperative Multicenter Neonatal Research Network | BELL, EDWARD F | UNIVERSITY OF IOWA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2006 to 2015 | NIH RePORTER |
| U10HD068263 | Rochester-Buffalo Neonatal Research Group | D'ANGIO, CARL T. | UNIVERSITY OF ROCHESTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
1 to 10 of 12
See all 12 grantsTrial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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