Results showed statistically significant benefit in the experimental group
NINOS
The Randomized Inhaled Nitric Oxide Study (NINOS) in Full-Term and Nearly Full-Term Infants With Hypoxic Respiratory Failure
Sponsor study identifier
Secondary identifiers
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
interventional
235
2 countries
20
Study Start
October 1995
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 1996
Actual (reported)Study Completion
May 1998
Actual (reported)Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1998
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1995
Date type not reportedThis date has not been verified as actual or estimated.
May 1996
Actual (reported)May 1998
Actual (reported)June 1, 2000
Actual (reported)June 2, 2000
Actual (reported)Death or initiation of ECMO
Before hospital discharge or 120 days of life
PaO2 levels, oxygenation index, and alveolar-arterial oxygen gradient
30 minutes after drug administration
Neurodevelopmental outcome
18-22 Months Corrected Age
Duration of hospital stay
At hospital discharge
Inhaled Nitric Oxide (iNO)
100% oxygen
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997 Feb 27;336(9):597-604. doi: 10.1056/NEJM199702273360901.
Inhaled nitric oxide and hypoxic respiratory failure in infants with congenital diaphragmatic hernia. The Neonatal Inhaled Nitric Oxide Study Group (NINOS). Pediatrics. 1997 Jun;99(6):838-45. doi: 10.1542/peds.99.6.838.
Richard A. Ehrenkranz, MD
Yale University
David K. Stevenson, MD
Stanford University
Raymond Bain, PhD
George Washington University
James A. Lemons, MD
Indiana University
235 participants (actual enrollment reported by the registry).
First Submitted
June 1, 2000
First Posted
June 2, 2000
Study Start
October 1995
Date type not reportedThis date has not been verified as actual or estimated.
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
Duration of assisted ventilation, air leaks, or chronic lung disease
At hospital discharge
Transfers for ECMO
At hospital discharge
Contact the study team to confirm eligibility.
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
McMaster University
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Université de Sherbrooke,
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Inhaled nitric oxide in term and near-term infants: neurodevelopmental follow-up of the neonatal inhaled nitric oxide study group (NINOS). J Pediatr. 2000 May;136(5):611-7. doi: 10.1067/mpd.2000.104826.
Sokol GM, Fineberg NS, Wright LL, Ehrenkranz RA. Changes in arterial oxygen tension when weaning neonates from inhaled nitric oxide. Pediatr Pulmonol. 2001 Jul;32(1):14-9. doi: 10.1002/ppul.1083.
Sokol GM, Ehrenkranz RA. Inhaled nitric oxide therapy in neonatal hypoxic respiratory failure: insights beyond primary outcomes. Semin Perinatol. 2003 Aug;27(4):311-9. doi: 10.1016/s0146-0005(03)00043-0.
Seetha Shankaran, MD
Wayne State University
Lu-Ann Papile, MD
University of New Mexico
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
Avroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital
William William Oh, MD
Brown University, Women & Infants Hospital of Rhode Island
Sheldon B. Korones, MD
University of Tennessee
Mary Wearden, MD
Baylor College of Medicine
N. Singhal, MD
Foothills Hospital, Calgary, Canada
Neil N. Finer, MD
Royal Alexandra Hospital
A. Solimano, MD
British Columbia Children's Hospital
C. Fajardo, MD
Health Sciences Center, Winnipeg, Manitoba
H. Kirpalani, MD
McMaster University
R. Walker, MD
Children's Hospital of Eastern Ontario
A. Johnston, MD
Montreal Children's Hospital of the MUHC
P. Blanchard, MD
Université de Sherbrooke, Sherbrooke, Quebec
K. Sankarhan, MD
Royal University Hospital, Saskatoon, Saskatchewan
Primary Completion
May 1996
Actual (reported)Study Completion
May 1998
Actual (reported)Last Updated
September 26, 2017
Record last verified: 2017-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: