Overview

NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Treatments:
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