NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
NCT00139217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2014-05-29
Summary
The primary objective of the trial is to determine the feasibility and clinical safety and efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after placement of a tracheal tube and the institution of mechanical ventilation.
Conditions
- Pulmonary Hypertension
Interventions
- DRUG
-
iNO
- PROCEDURE
-
Non-invasive nitric oxide
Sponsors & Collaborators
-
Emory University
lead OTHER
Principal Investigators
-
Golde Dudell, M.D. · Emory University, Department of Pediatrics, Division of Neonatology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
Countries
- United States
Study Locations
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