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Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

NCT01748045 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-07-19

Study results available
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Summary

The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

DRUG

inhaled nitric oxide

DRUG

Placebo Comparator - nitrogen gas

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Jennifer W Lee, MD, MS · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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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 NCT01748045 on ClinicalTrials.gov