Brief Title
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
Official Title
Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia
Brief 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.
Detailed Description
This is a single center, blinded, randomized control clinical trial to evaluate the effects of inhaled nitric oxide on the outcome of survival and incidence of bronchopulmonary dysplasia. This trial has a planned enrollment of 138 infants with 68 infants with delayed pulmonary transition assigned to either the treatment or placebo group. There is no enrollment restriction based on gender, ethnicity, or race. Enrollment is expected to take 36 months with an additional 12 months for data analysis.Infants with early pulmonary hypertension will be randomized to the treatment or placebo group. Treatment will continue until resolution of pulmonary hypertension or through Day 14, whichever comes first. Serial echocardiograms will be performed every 48 hours +/-12 hours until Day 14. Oxygen saturation levels will be averaged every 24 hour period following enrollment. This study will provide evidence for the beneficial effects of early diagnosis and treatment of pulmonary hypertension in preterm infants.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Death (yes/no)
Secondary Outcome
Pulmonary arterial pressure (mmHg)
Condition
Pulmonary Hypertension
Intervention
inhaled nitric oxide
Study Arms / Comparison Groups
Treatment group - active
Description: inhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
138
Start Date
July 15, 2019
Completion Date
August 2021
Primary Completion Date
August 2021
Eligibility Criteria
Inclusion Criteria: Step 1: - Birth between 23 weeks and 0 days and 29 weeks and 6 days. - Positive pressure ventilation at 72-96 hours of age Step 2: - Early pulmonary hypertension Exclusion Criteria: Step 1: - Death prior to 12 hours of age or first echocardiogram - Chromosomal anomalies - Major congenital anomalies - Myocardial dysfunction - Complex cardiac defect - Dependent on right to left shunting of blood Step 2: - Excessive pulmonary blood flow (left to right shunt across PDA) - Pulmonary blood flow obstruction secondary to pulmonary vein stenosis - Mitral valve stenosis - Cor triata - Aortic valve atresia
Gender
All
Ages
23 Weeks - 29 Weeks
Accepts Healthy Volunteers
No
Contacts
Hussnain Mirza, MD, 407-303-2528, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03576885
Organization ID
1170748
Responsible Party
Sponsor
Study Sponsor
AdventHealth
Collaborators
Mallinckrodt
Study Sponsor
Hussnain Mirza, MD, Principal Investigator, AdventHealth
Verification Date
August 2019