Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

PHASE3TerminatedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

August 31, 1998

Primary Completion Date

May 31, 2001

Study Completion Date

August 31, 2003

Conditions
Infant, NewbornHypertension, PulmonaryPersistent Fetal Circulation SyndromePneumonia, AspirationRespiratory Distress Syndrome, NewbornRespiratory Insufficiency
Interventions
DRUG

Inhaled Nitric Oxide

Study gas was initiated at a concentration of 5 ppm, and the dose was increased to 20 ppm when the infant had \<=20 mm Hg increase in PaO2 (less than full response).

DRUG

Standard iNO therapy

Begin a sham initiation of iNO in term and near-term infants in respiratory failure with an oxygenation index (OI) between 15-25; initiated actual iNO therapy based on standard threshold (OI \>=25).

Trial Locations (18)

30303

Emory University, Atlanta

33136

University of Miami, Miami

35233

University of Alabama at Birmingham, Birmingham

38163

University of Tennessee, Memphis

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

Texas Children's Hospital, Houston

University of Texas Health Science Center at Houston, Houston

85013

St. Joseph's Hospital, Phoenix

87131

University of New Mexico, Albuquerque

92130

San Diego Children's Hospital, San Diego

94304

Stanford University, Palo Alto

98195

University of Washington School of Medicine, Seattle

06504

Yale University, New Haven

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Mallinckrodt

INDUSTRY

lead

NICHD Neonatal Research Network

NETWORK

NCT00005773 - Early Inhaled Nitric Oxide for Respiratory Failure in Newborns | Biotech Hunter | Biotech Hunter