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Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
Not Recruiting
Trial ID: NCT00005776
Purpose
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.
Official Title
The Randomized Inhaled Nitric Oxide Study (NINOS) in Full-Term and Nearly Full-Term Infants With Hypoxic Respiratory Failure
Stanford Investigator(s)
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
Intervention(s):
drug: Inhaled nitric oxide
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305