Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931632
• Other study ID #: IK-3001-BPD-301
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2009
• Last updated: October 30, 2017
• Start date: November 2009
• Est. completion date: May 2014

Study information

• Verified date: October 2017
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

Description:

Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Preterm infants who are:

1. 500 to 1250 grams at birth

2. < 30 weeks gestational age

3. 5 to 14 days of age (inclusive) at the time of entry

4. Requiring mechanical ventilation or for those infants = 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)

Exclusion Criteria:

1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care

2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)

3. Subjects who are dependent on right to left shunting to maintain the systemic circulation

4. Preterm infants who received prior iNO therapy

5. Use of another investigational agent

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Drug:
• Inhaled Nitric Oxide
Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
• Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Centre Hospitalier Universitaire de Quebec	Quebec
United States	Medical College of Georgia	Augusta	Georgia
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Loma Linda University School of Medicine	Loma Linda	California
United States	University of Louisville School of Medicine	Louisville	Kentucky
United States	Wheaton Franciscan Healthcare	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Jersey Shore University Medical Center	Neptune City	New Jersey
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Children's Hospital of Orange County	Orange	California
United States	Winnie Palmer Hospital for Women and Babies	Orlando	Florida
United States	Stanford University School of Medicine	Palo Alto	California
United States	Advocate Lutheran General Children's Hospital	Park Ridge	Illinois
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	WakeMed Faculty Physicians, Neonatology	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Rady Children's Hospital of San Diego	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	Sanford Children's Hospital	Sioux Falls	South Dakota
United States	University of So Florida College of Medicine	Tampa	Florida
United States	Montefiore Medical Center	The Bronx	New York
United States	Mercy Children's Hospital	Toledo	Ohio
United States	Saint Francis Children's Hospital	Tulsa	Oklahoma
United States	Maria Fareri Children's Hospital at Westchester Medical Center	Valhalla	New York
United States	Children's Corporate Center, Division of Neonatology	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinica — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Without BPD at 36 Weeks		Baseline, 36 weeks PMA
Secondary	Days of Airway Pressure Support - Intent-to-treat Population	Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.	Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Length of Birth Hospitalization		Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia		Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason		Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Systemic Use of Postnatal Corticosteroids for Any Medical Reason		Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Number of Days of Oxygen Use		Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Secondary	Severity of Bronchopulmonary Dysplasia	Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.	36 weeks

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