Trial Search Results
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
NICHD Neonatal Research Network
Collaborator: Medical Research Council of Canada
Stanford Investigator(s):
Intervention(s):
- Drug: Inhaled nitric oxide
- Drug: Placebo
Phase:
Phase 3
Eligibility
Inclusion Criteria:
- Greater than 34 wks gestational age
- One or more of the following diagnoses: primary pulmonary hypertension of the newborn,
respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis,
suspected pulmonary hypoplasia
- Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at
least 15 min apart
- Indwelling arterial line
- Echocardiography before randomization
- Parental consent
Exclusion Criteria:
- Congenital diaphragmatic hernia
- Known congenital heart disease
- Decision not to provide full therapy
Ages Eligible for Study
N/A - 14 Days
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting