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Trial record 1 of 1 for:    treatment of delayed pulmonary transition in extremely preterm infants
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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
Sponsor:
Collaborators:
Mallinckrodt
Thrasher Research Fund
Information provided by (Responsible Party):
AdventHealth

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Bronchopulmonary Dysplasia Drug: inhaled nitric oxide Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Masked randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
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



Primary Outcome Measures :
  1. Death (yes/no) [ Time Frame: 36 weeks post menstrual age ]
    Incidence of death

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. SF (SpO2/FiO2) ratio [ Time Frame: Duration of treatment or up to Day 14 ]
    Pulse oximetric saturation Spo2/Fio2 ratio



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Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Hussnain Mirza, MD 407-303-2528 hussnain.mirza.md@flhosp.org
Contact: Debbie Ott, RN, BSN 407-303-6983 deborah.ott@flhosp.org

Locations
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United States, Florida
AdventHealth Recruiting
Orlando, Florida, United States, 32803
Contact: Hussnain Mirza, MD    407-303-2528    hussnain.mirza@adventhealth.org   
Sponsors and Collaborators
AdventHealth
Mallinckrodt
Thrasher Research Fund
Investigators
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Principal Investigator: Hussnain Mirza, MD AdventHealth
Publications:
Abman SH, Hansmann G, Archer SL, Ivy DD, Adatia I, Chung WK, Hanna BD, Rosenzweig EB, Raj JU, Cornfield D, Stenmark KR, Steinhorn R, Thébaud B, Fineman JR, Kuehne T, Feinstein JA, Friedberg MK, Earing M, Barst RJ, Keller RL, Kinsella JP, Mullen M, Deterding R, Kulik T, Mallory G, Humpl T, Wessel DL; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; and the American Thoracic Society. Pediatric Pulmonary Hypertension: Guidelines From the American Heart Association and American Thoracic Society. Circulation. 2015 Nov 24;132(21):2037-99. doi: 10.1161/CIR.0000000000000329. Epub 2015 Nov 3. Erratum in: Circulation. 2016 Jan 26;133(4):e368.

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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT03576885    
Other Study ID Numbers: 1170748
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchopulmonary Dysplasia
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents