Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
Public ClinicalTrials.gov record NCT00005773. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Early Inhaled Nitric Oxide Therapy in Term and Near Term Infants With Respiratory Failure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at \>34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) \>15 and \<25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.
Study identification
- NCT ID
- NCT00005773
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 302 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Up to 14 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1998 (Type not available)
- Primary completion
- May 2001 (Actual)
- Completion
- Aug 2003 (Actual)
- Last update posted
- Sep 26, 2017
1998 – 2003
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| St. Joseph's Hospital | Phoenix | Arizona | 85013 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| San Diego Children's Hospital | San Diego | California | 92130 | — |
| Yale University | New Haven | Connecticut | 06504 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Tennessee | Memphis | Tennessee | 38163 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Washington School of Medicine | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00005773, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00005773 live on ClinicalTrials.gov.