TerminatedPhase 3

Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

Stopped: Results showed statistically significant benefit in the experimental group

United States235 participantsStarted 1995-10

Plain-language summary

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.

Who can participate

Age range14 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Death or initiation of ECMO

Timeframe: Before hospital discharge or 120 days of life

Trial details

NCT IDNCT00005776

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion1996-05

View on ClinicalTrials.gov More Infant, Newborn trials