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NCT00005776 · ClinicalTrials.gov registry record · Phase 3

Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

A Phase 3 study, sponsored by NICHD Neonatal Research Network.

Terminated
Registry status
Phase 3
Development phase
235
Enrollment target

NCT00005776: Clinical Trial Phase 3 study, sponsored by NICHD Neonatal Research Network.

NCT00005776 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 235 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005776, a Phase 3 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.

TERMINATED
Registry status
Phase 3
Development phase
235 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Inhaled nitric oxide

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 1995-10
Est. Completion 1998-05
Phase Phase 3
NICHD Neonatal Research Network

61 total trials

Why NCT00005776 stopped before completion

NCT00005776 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00005776 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005776 about?

NCT00005776 is a clinical study titled "Inhaled Nitric Oxide Study for Respiratory Failure in Newborns". 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 inhal...

What is the current status of trial NCT00005776?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 1995-10. Estimated completion is 1998-05.

What interventions are being tested in trial NCT00005776?

The interventions under investigation include: Placebo (DRUG), Inhaled nitric oxide (DRUG).

Who is sponsoring clinical trial NCT00005776?

This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00005776's enrollment target sits among peer trials

235 1296th of 2000 higher than 704 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00005776, the US trial registry maintained by the National Library of Medicine. NCT00005776 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.