Inhaled Nitric Oxide Study for Respiratory Failure in Newborns (NINOS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00005776 |
|
Recruitment Status :
Terminated
(Results showed statistically significant benefit in the experimental group)
First Posted : June 2, 2000
Last Update Posted : September 26, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Hypertension, Pulmonary Persistent Fetal Circulation Syndrome Pneumonia, Aspiration Respiratory Distress Syndrome, Newborn Respiratory Insufficiency | Drug: Inhaled nitric oxide Drug: Placebo | Phase 3 |
Respiratory failure in term newborns is associated with significant morbidity and mortality, despite maximal conventional therapy. Neonates with pulmonary hypertension have been treated with iNO, a selective pulmonary vasodilator. This multicenter, double-masked placebo-controlled randomized trial tested whether iNO would reduce the risk of death and/or the initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. The sample size was based on a reduction of the primary event (death or ECMO) from 50 percent to 30 percent; 90 percent power; and a two-tailed Type I error of 0.05.
Infants were evaluated at baseline for pulmonary, cardiac, bleeding status, and therapies received. Those who were greater than 34 wks gestation and 14 days old or less and required assisted ventilation with an OI (mean airway pressure x FiO2 divided by the PaO2 x 100) greater than 25 were eligible. They were randomly assigned to receive iNO at 20 ppm or 100 percent oxygen as a control. Infants whose PaO2 increased by less than 20 mm Hg after 30 minutes were studied at 80ppm iNO or control gas.; MetHg and NO2 concentrations were monitored regularly. Management, including surfactant administration, included prospectively defined criteria for study gas response, escalation, reinitiation, and weaning. The maximum total time on study gas was 336 hrs (after 240 hrs, the INO concentration was required to be no more than 5 ppm). Patients were followed to death, discharge, or 120 days and evaluated at 18-24 mos by a masked certified examiner.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 235 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Randomized Inhaled Nitric Oxide Study (NINOS) in Full-Term and Nearly Full-Term Infants With Hypoxic Respiratory Failure |
| Study Start Date : | October 1995 |
| Actual Primary Completion Date : | May 1996 |
| Actual Study Completion Date : | May 1998 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Inhaled Nitric Oxide
Inhaled Nitric Oxide (iNO)
|
Drug: Inhaled nitric oxide
Inhaled Nitric oxide at a concentration of 20 ppm |
|
Placebo Comparator: Oxygen
100% oxygen
|
Drug: Placebo
100% Oxygen |
- Death or initiation of ECMO [ Time Frame: Before hospital discharge or 120 days of life ]
- PaO2 levels, oxygenation index, and alveolar-arterial oxygen gradient [ Time Frame: 30 minutes after drug administration ]
- Neurodevelopmental outcome [ Time Frame: 18-22 Months Corrected Age ]
- Duration of hospital stay [ Time Frame: At hospital discharge ]
- Duration of assisted ventilation, air leaks, or chronic lung disease [ Time Frame: At hospital discharge ]
- Transfers for ECMO [ Time Frame: At hospital discharge ]
- Meeting ECMO criteria [ Time Frame: At hospital discharge ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 14 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Greater than 34 wks gestational age
- One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia
- Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart
- Indwelling arterial line
- Echocardiography before randomization
- Parental consent
Exclusion Criteria:
- Congenital diaphragmatic hernia
- Known congenital heart disease
- Decision not to provide full therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005776
Show 20 study locations
| Study Director: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Raymond Bain, PhD | George Washington University | |
| Principal Investigator: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | William William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee | |
| Principal Investigator: | Mary Wearden, MD | Baylor College of Medicine | |
| Principal Investigator: | N. Singhal, MD | Foothills Hospital, Calgary, Canada | |
| Principal Investigator: | Neil N. Finer, MD | Royal Alexandra Hospital | |
| Principal Investigator: | A. Solimano, MD | British Columbia Children's Hospital | |
| Principal Investigator: | C. Fajardo, MD | Health Sciences Center, Winnipeg, Manitoba | |
| Principal Investigator: | H. Kirpalani, MD | McMaster University | |
| Principal Investigator: | R. Walker, MD | Children's Hospital of Eastern Ontario | |
| Principal Investigator: | A. Johnston, MD | Montreal Children's Hospital of the MUHC | |
| Principal Investigator: | P. Blanchard, MD | Université de Sherbrooke, Sherbrooke, Quebec | |
| Principal Investigator: | K. Sankarhan, MD | Royal University Hospital, Saskatoon, Saskatchewan |
Publications of Results:
|
NICHD Neonatal Research Network Hypertension, pulmonary Hypoxic respiratory failure Meconium aspiration Methemoglobinemia Nitric oxide |
Oxygen inhalation therapy Persistent Fetal Circulation Syndrome Pneumonia, aspiration Respiratory distress syndrome Respiratory insufficiency Severe respiratory failure |
|
Pneumonia Pneumonia, Aspiration Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Hypertension, Pulmonary Persistent Fetal Circulation Syndrome Hypertension Syndrome Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Respiratory Tract Infections Infections |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action |