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Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

NCT03576885 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-15

Study results available
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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.

Conditions

  • Pulmonary Hypertension
  • Bronchopulmonary Dysplasia

Interventions

DRUG

inhaled nitric oxide

inhaled nitric oxide will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension

DRUG

Placebo

placebo will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Thrasher Research Fund

    collaborator OTHER

  • AdventHealth

    lead OTHER

Principal Investigators

  • Hussnain Mirza, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2023-10-09
Completion
2023-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576885 on ClinicalTrials.gov