Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
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|ClinicalTrials.gov Identifier: NCT03576885|
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : May 6, 2021
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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Bronchopulmonary Dysplasia||Drug: inhaled nitric oxide Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Masked randomized controlled trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Treatment group - active
inhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.
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
Other Name: iNO
Placebo Comparator: Treatment group - placebo
Placebo treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.
placebo will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension
No Intervention: Control group
Enrolled infants with no evidence of pulmonary hypertension will serve as the control group for incidence of death or bronchopulmonary hypertension
- Death (yes/no) [ Time Frame: 36 weeks post menstrual age ]Incidence of death
- Bronchopulmonary (BPD) dysplasia (yes/no) [ Time Frame: 36 weeks post menstrual age ]Incidence of bronchopulmonary dysplasia as determined by need for positive pressure ventilation or supplemental oxygen after room air challenge test
- Pulmonary arterial pressure (mmHg) [ Time Frame: Duration of treatment or up to Day 14 ]Pulmonary arterial pressure will be averaged for each 24-48 hour period after enrollment
- Oxygen saturation level percentage [ Time Frame: Duration of treatment or up to Day 14 ]Oxygen saturation level will be averaged for each 24 hour period after enrollment
- SF (SpO2/FiO2) ratio [ Time Frame: Duration of treatment or up to Day 14 ]Pulse oximetric saturation Spo2/Fio2 ratio
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576885
|Contact: Hussnain Mirza, MDemail@example.com|
|Contact: Debbie Ott, RN, BSNfirstname.lastname@example.org|
|United States, Florida|
|Orlando, Florida, United States, 32803|
|Contact: Hussnain Mirza, MD 407-303-2528 email@example.com|
|Principal Investigator:||Hussnain Mirza, MD||AdventHealth|