Overview
NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
Status:
Completed
Completed
Trial end date:
2007-09-01
2007-09-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Emory UniversityTreatments:
Nitric Oxide
Criteria
Inclusion Criteria:- 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 Criteria:
- Infants with significant lung disease
- Inability to sustain spontaneous respirations
- Lethal congenital anomalies
- Severe birth asphyxia