Status:
COMPLETED
NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
Lead Sponsor:
Emory University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
Phase:
NA
Brief 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 +-parenchyma...
Detailed Description
Blending low doses of NO gas with oxygen in the inspiratory limb of mechanical ventilators is an effective method for reducing pulmonary vascular resistance and decreasing extrapulmonary right-to-left...
Eligibility Criteria
Inclusion
- Newborn infants \>/= 34 weeks with clinical or echocardiographic evidence of PPHN with a PaO2 \< 100 of Fio2 0.8 who are not mechanically ventilated
Exclusion
- Infants with significant lung disease
- Inability to sustain spontaneous respirations
- Lethal congenital anomalies
- Severe birth asphyxia
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00139217
Start Date
August 1 2005
End Date
September 1 2007
Last Update
May 29 2014
Active Locations (1)
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1
Emory University affiliated newborn intensive care units
Atlanta, Georgia, United States, 30322