drugset / Trial / NCT03576885

Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

NCT03576885

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants. 1. To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD. 2. To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.

Timeline

Start
2019-07-15
Primary completion
2023-10-09
Completion
2023-10-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitric Oxide Other / unclassified 20 ppm Inhaled