Back to resultsInhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, BPD
Eligibility Criteria
Inclusion Criteria:
Preterm infants who are:
- 500 to 1250 grams at birth
- < 30 weeks gestational age
- 5 to 14 days of age (inclusive) at the time of entry
- 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:
- 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
- Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
- Subjects who are dependent on right to left shunting to maintain the systemic circulation
- Preterm infants who received prior iNO therapy
- Use of another investigational agent
Sites / Locations
- Phoenix Children's Hospital
- St. Joseph's Hospital and Medical Center
- Loma Linda University School of Medicine
- Children's Hospital of Orange County
- Stanford University School of Medicine
- Rady Children's Hospital of San Diego
- Sharp Mary Birch Hospital for Women and Newborns
- Connecticut Children's Medical Center
- Winnie Palmer Hospital for Women and Babies
- University of So Florida College of Medicine
- Medical College of Georgia
- Advocate Lutheran General Children's Hospital
- Riley Hospital for Children
- University of Louisville School of Medicine
- Hennepin County Medical Center
- Saint Barnabas Medical Center
- Jersey Shore University Medical Center
- Robert Wood Johnson University Hospital
- Winthrop University Hospital
- Montefiore Medical Center
- Maria Fareri Children's Hospital at Westchester Medical Center
- WakeMed Faculty Physicians, Neonatology
- Mercy Children's Hospital
- Saint Francis Children's Hospital
- Greenville Memorial Hospital
- Sanford Children's Hospital
- Cook Children's Medical Center
- Primary Children's Medical Center
- Virginia Commonwealth University
- Wheaton Franciscan Healthcare
- Children's Corporate Center, Division of Neonatology
- University of Calgary
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Inhaled Nitric Oxide
Placebo
Arm Description
Inhaled Nitric Oxide
Nitrogen Placebo
Outcomes
Primary Outcome Measures
Survival Without BPD at 36 Weeks
Secondary Outcome Measures
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.
Length of Birth Hospitalization
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Number of Days of Oxygen Use
Severity of Bronchopulmonary Dysplasia
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00931632
Brief Title
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, BPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
451 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled Nitric Oxide
Arm Type
Experimental
Arm Description
Inhaled Nitric Oxide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nitrogen Placebo
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Other Intervention Name(s)
INOmax
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nitrogen gas
Intervention Description
Nitrogen gas will be administered in the same manner as the experimental drug.
Primary Outcome Measure Information:
Title
Survival Without BPD at 36 Weeks
Time Frame
Baseline, 36 weeks PMA
Secondary Outcome Measure Information:
Title
Days of Airway Pressure Support - Intent-to-treat Population
Description
Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Length of Birth Hospitalization
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Number of Days of Oxygen Use
Time Frame
Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Title
Severity of Bronchopulmonary Dysplasia
Description
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants who are:
500 to 1250 grams at birth
< 30 weeks gestational age
5 to 14 days of age (inclusive) at the time of entry
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:
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
Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
Subjects who are dependent on right to left shunting to maintain the systemic circulation
Preterm infants who received prior iNO therapy
Use of another investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Baldassarre, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Loma Linda University School of Medicine
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rady Children's Hospital of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Winnie Palmer Hospital for Women and Babies
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of So Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Advocate Lutheran General Children's Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune City
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Maria Fareri Children's Hospital at Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
WakeMed Faculty Physicians, Neonatology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Mercy Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Saint Francis Children's Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford Children's Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Wheaton Franciscan Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Facility Name
Children's Corporate Center, Division of Neonatology
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28973344
Citation
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 Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.
Results Reference
result
Learn more about this trial
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
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