Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03576885
Study type Interventional
Source Florida Hospital
Contact Hussnain Mirza, MD
Phone 407-303-2528
Email hussnain.mirza.md@flhosp.org
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 2018
Completion date August 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT01950585 - Hydroxyurea in Pulmonary Arterial Hypertension Early Phase 1
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Recruiting NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Completed NCT01894035 - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Not yet recruiting NCT02748798 - Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders Early Phase 1
Enrolling by invitation NCT02633293 - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE Phase 2/Phase 3
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Completed NCT02216279 - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension Phase 2
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Completed NCT02821156 - Study on the Use of Inhaled NO (iNO) N/A
Recruiting NCT01913847 - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT02377934 - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study N/A
Recruiting NCT01091012 - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension Phase 3
Recruiting NCT02275793 - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure N/A
Completed NCT00739375 - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension. Phase 1
Completed NCT01484899 - Smoking: a Risk Factor for Pulmonary Arterial Hypertension? N/A
Completed NCT01463514 - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension N/A
Recruiting NCT02061787 - the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension