Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia

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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

December 2021

Primary Completion Date

December 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

May 2021