At a glance

ClinicalIndex Comparison Record

Phase 3Terminated· 302 enrolled

Drug / intervention

Inhaled Nitric Oxide +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005773

NCT00005773Phase 3Terminated

Terminated

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Early Inhaled Nitric Oxide Therapy in Term and Near Term Infants With Respiratory Failure

NICHD Neonatal Research Network·interventional·Posted Jun 2, 2000·Updated Sep 26, 2017

In Brief

A Phase 3 clinical trial evaluating Inhaled Nitric Oxide and Standard iNO therapy for Infant, Newborn and 5 related conditions. Terminated early, enrolled 302 participants across 18 sites.

Signals

Trial was terminated early

Detailed Summary

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 Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Hypertension, Pulmonary, Persistent Fetal Circulation Syndrome, Pneumonia, Aspiration, Respiratory Distress Syndrome, Newborn, Respiratory Insufficiency

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR), Canadian Institutes of Health Research (CIHR), Mallinckrodt

Timeline

Phase 3TerminatedFinished

199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 1998

First PostedJun 2000

Primary CompletionMay 2001

Study CompletionAug 2003

TodayJul 2026

First PostedJun 2, 2000

Enrollment StartAug 1, 1998

Primary CompletionMay 1, 2001

Study CompletionAug 1, 2003

TodayJul 1, 2026

Enrollment to primary: 2.8 yearsPosted 26.1 years ago

Interventions

Inhaled Nitric Oxidedrug

Study gas was initiated at a concentration of 5 ppm, and the dose was increased to 20 ppm when the infant had \<=20 mm Hg increase in PaO2 (less than full response).

Standard iNO therapydrug

Begin a sham initiation of iNO in term and near-term infants in respiratory failure with an oxygenation index (OI) between 15-25; initiated actual iNO therapy based on standard threshold (OI \>=25).