At a glance

ClinicalIndex Comparison Record

Phase 3Terminated· 235 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/NCT00005776

NCT00005776Phase 3Terminated

Terminated

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The Randomized Inhaled Nitric Oxide Study (NINOS) in Full-Term and Nearly Full-Term Infants With Hypoxic 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 Placebo for Infant, Newborn and 5 related conditions. Terminated early, enrolled 235 participants across 20 sites in 2 countries.

Signals

Trial was terminated early

Detailed Summary

Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of 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

CountriesCanada, United States

CollaboratorsMedical Research Council of Canada, National Center for Research Resources (NCRR)

Timeline

Phase 3TerminatedFinished

199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 1995

Primary CompletionMay 1996

Study CompletionMay 1998

First PostedJun 2000

TodayJul 2026

First PostedJun 2, 2000

Enrollment StartOct 1, 1995

Primary CompletionMay 1, 1996

Study CompletionMay 1, 1998

TodayJul 1, 2026

Enrollment to primary: 7 monthsPosted 26.1 years ago

Interventions

Inhaled nitric oxidedrug

Inhaled Nitric oxide at a concentration of 20 ppm

Placebodrug

100% Oxygen