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

PHASE3CompletedINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2014

Conditions
Bronchopulmonary Dysplasia
Interventions
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.

DRUG

Placebo

Nitrogen gas will be administered in the same manner as the experimental drug.

Trial Locations (33)

10461

Montefiore Medical Center, The Bronx

10595

Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla

11501

Winthrop University Hospital, Mineola

23298

Virginia Commonwealth University, Richmond

27610

WakeMed Faculty Physicians, Neonatology, Raleigh

29605

Greenville Memorial Hospital, Greenville

30912

Medical College of Georgia, Augusta

32806

Winnie Palmer Hospital for Women and Babies, Orlando

33606

University of So Florida College of Medicine, Tampa

40202

University of Louisville School of Medicine, Louisville

43608

Mercy Children's Hospital, Toledo

46202

Riley Hospital for Children, Indianapolis

53210

Wheaton Franciscan Healthcare, Milwaukee

53226

Children's Corporate Center, Division of Neonatology, Wauwatosa

55415

Hennepin County Medical Center, Minneapolis

57117

Sanford Children's Hospital, Sioux Falls

60068

Advocate Lutheran General Children's Hospital, Park Ridge

74136

Saint Francis Children's Hospital, Tulsa

76104

Cook Children's Medical Center, Fort Worth

84113

Primary Children's Medical Center, Salt Lake City

85006

Phoenix Children's Hospital, Phoenix

85013

St. Joseph's Hospital and Medical Center, Phoenix

92123

Rady Children's Hospital of San Diego, San Diego

Sharp Mary Birch Hospital for Women and Newborns, San Diego

92354

Loma Linda University School of Medicine, Loma Linda

92868

Children's Hospital of Orange County, Orange

94304

Stanford University School of Medicine, Palo Alto

06106

Connecticut Children's Medical Center, Hartford

07039

Saint Barnabas Medical Center, Livingston

07754

Jersey Shore University Medical Center, Neptune City

08901

Robert Wood Johnson University Hospital, New Brunswick

T2N 4N1

University of Calgary, Calgary

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY