Lung Diseases Clinical Trial
Official title:
Study of the Long-term Outcomes of Nitric Oxide for Ventilated Premature Babies
Verified date | May 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to look at the long term consequences of prematurity in infants treated with inhaled nitric oxide (iNO) while in the neonatal intensive care unit.
Status | Completed |
Enrollment | 652 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 48 Hours |
Eligibility |
Inclusion Criteria: - Enrolled in "Inhaled NO for the Prevention of Chronic Lung Disease" trial (ClinicalTrials.gov Identifier: NCT00006401). Exclusion Criteria: - Did not consent to extended follow-up. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the cost-effectiveness of iNO in ventilated premature infants using: long term clinical and childhood developmental outcomes; family impact; and healthcare costs of prematurity-associated respiratory failure | Five Years | No |
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