Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Non-invasive Inhaled Nitric Oxide in Premature Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955487
• Other study ID #: 06-0124
• Secondary ID: 5P50HL0849235 P5
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2009
• Last updated: June 3, 2016
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: June 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.

Description:

BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and hypoxemic respiratory failure—both of which are abnormal lung conditions—in full-term newborns. However, in babies born prematurely, the effects of iNO on lung function are not well defined. Also, previous studies have mainly examined whether iNO reduces the incidence of BPD in newborns who are on mechanical ventilation. However, intubation and mechanical ventilation of premature newborns is now increasingly being avoided, and non-invasive support, including the use of nasal continuous positive airway pressure (NCPAP), is being used. Early treatment with low-dose iNO may reduce the incidence of BPD in premature newborns who do not require mechanical ventilation and intubation after delivery. The purpose of this study is to determine if low-dose, non-invasive iNO reduces the risk of BPD, pulmonary hypertension, and death in premature newborns who do not require mechanical ventilation.

This study will enroll premature newborns who require extra oxygen but do not require intubation or mechanical ventilation for respiratory failure in the first 72 hours of life. Participants will be randomly assigned to receive low-dose, non-invasive iNO or nitrogen (placebo) during their hospital stay. While hospitalized, participants' heart rate, blood oxygen level breathing rate, blood pressure, and medications will be monitored, and blood collection will occur at various times. Monitoring will continue until participants are 30 weeks corrected gestational age or for at least 14 days if participants are born at 29 weeks or more. All participants will undergo an ultrasound of the head when they are 7 days, 28 days, and 36 weeks of age. They will undergo an echocardiogram, which is an ultrasound of the heart, at 7 and 21 days of age and 4 weeks before the original expected due date. A chest x-ray will be performed before hospital discharge, and a breathing status test will be performed either 4 weeks before participants' original expected due date or before hospital discharge. Follow-up study visits will occur at Years 1 and 2, and will include a physical examination and developmental and behavioral testing. Another echocardiogram will also be performed at the Year 1 visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

• Birth weight of 500-1250 grams and gestational age of less than 34 weeks

• Age at enrollment is less than 72 hours

• Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

Exclusion Criteria:

• Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)

• Presence of lethal congenital anomaly

• Participating in another concurrent experimental study

• Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly BUT they must be extubated at the time of consent and study entry prior to 72 hours of life)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth

Intervention

Drug:
• Inhaled Nitric Oxide (iNO)
iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
• Nitrogen (placebo)
Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).

Locations

Country	Name	City	State
United States	Children's Hospital and University Colorado Hospital	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of bronchopulmonary dysplasia and mortality		Week 36 or earlier, if participants are discharged from the hospital	No
Secondary	Pulmonary hypertension		Week 36 or earlier, if participants are discharged from the hospital	No