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Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

NCT00152542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-06-12

No results posted yet for this study

Summary

Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.

Conditions

  • Prematurity, Respiratory Distress Syndrome,Hypoxemia

Interventions

DRUG

Inhaled nitric oxide

1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7

DRUG

Placebo

No iNO given for days 1-7

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Michael D Schreiber, M.D. · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152542 on ClinicalTrials.gov