TerminatedPhase 2/3

Inhaled Nitric Oxide and Neuroprotection in Premature Infants

Stopped: The pace of patient enrolledment forced recruitment to stop after 273 patients.

United States273 participantsStarted 2008-05

Plain-language summary

The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.

Who can participate

Age range2 Hours – 72 Hours

SexALL

See this in plain English?

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

Inclusion Criteria: * Prematurity (birthweight ≤ 1500g, \< 31 weeks gestation) * Requiring respiratory support * Admitted to the NICU at the University of Chicago Exclusion Criteria: * Severe congenital anomalies * Genetic syndromes * Extremely sick preterm infants requiring very high ventilatory pressures (OI ≥ 20) * Premature infants judged by the physician as nonviable

What they're measuring

Neurodevelopment

Timeframe: Two years

Bronchopulmonary Dysplasia (BPD) or Death

Timeframe: 36 weeks of age corrected (BPD) or before discharge (death)

Trial details

NCT IDNCT00515281

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-07

Results submitted2024-07-17

View on ClinicalTrials.gov More Prematurity trials