Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure (Preemie iNO)
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|ClinicalTrials.gov Identifier: NCT00016523|
Recruitment Status : Terminated (Preliminary results showed increased intraventricular hemorrhage (IVH) in experimental arm)
First Posted : May 16, 2001
Last Update Posted : September 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Respiratory Distress Syndrome (RDS) Sepsis Pneumonia Hypertension, Pulmonary||Drug: Inhaled nitric oxide Drug: Placebo||Phase 3|
This multicenter, randomized, double-masked, controlled clinical trial evaluated the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia.
Infants were followed until death or discharge to home. The trial compared iNO therapy to mock gas delivery as the control, and otherwise incorporated conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy).
During the initial dosing, iNO was started at 5 ppm and could be increased to 10 ppm. If the infant did not respond, study gas was discontinued. For infants who responded to study gas, a gradual weaning was initiated. The total exposure to study gas did not exceed 336 hours (14 days). Infants were monitored for signs of toxicity.
Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked, certified examiners.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||May 2006|
Experimental: Inhaled Nitric Oxide
Inhaled Nitric Oxide
Drug: Inhaled nitric oxide
Started at 5 ppm and could be increased to 10 ppm
Active Comparator: Placebo
Started at 5 ppm and could be increased to 10 ppm
- Death or Bronchopulmonary Dysplasia [ Time Frame: At 36 weeks post-conceptional age ]
- Intraventricular Hemorrhage Grade III and IV [ Time Frame: At 36 weeks post-conceptional age ]
- Days on assisted ventilation [ Time Frame: At 36 weeks post-conceptional age ]
- Length of hospitalization [ Time Frame: At hospital discharge ]
- Retinopathy of prematurity [ Time Frame: At hospital discharge ]
- Air leaks [ Time Frame: At 36 weeks post-conceptual age ]
- Days on oxygen [ Time Frame: At 36 weeks post-conceptual age ]
- Supplemental oxygen [ Time Frame: At 36 weeks post-conceptual age ]
- Neurodevelopmental outcome [ Time Frame: 18-22 months corrected age ]
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|Ages Eligible for Study:||up to 120 Hours (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Any infant with a birth weight 401 - 1500 grams and < 34 weeks gestational age with an OI (mean Paw x FiO2 x 100/PaO2) > 10 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.
- Infants > 1500 grams and < 34 weeks gestational age will be entered in the Larger Preemie Pilot Study if they have an OI greater than or equal to 15 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.
- Infants requiring assisted ventilation with a diagnosis of RDS/HMD, pneumonia and/or sepsis, aspiration syndrome, idiopathic pulmonary hypertension, or suspected pulmonary hypoplasia associated with PROM and/or oligohydramnios.
- Greater than or equal to 4 hours after one dose of surfactant.
- Less than or equal to 120 hours of age.
- All infants must have an indwelling arterial line.
- Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies or severe birth asphyxia).
- Known structural congenital heart disease, except patent ductus arteriosus and atrial-level shunts.
- Infants with any major abnormality involving the respiratory system such as congenital diaphragmatic hernia, tracheoesophageal fistula or cystic fibrosis.
- Any bleeding diathesis considered to be clinically significant or thrombocytopenia with platelet count < 50,000.
- Prior enrollment into a conflicting clinical trial such as the Neonatal Network Surfactant CPAP trial.Inclusion Criteria
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): NCT00016523
|Study Director:||Krisa P. Van Meurs, MD||Stanford University|
|Principal Investigator:||Waldemar A. Carlo, MD||University of Alabama at Birmingham|
|Principal Investigator:||Abbot R. Laptook, MD||Brown University, Women & Infants Hospital of Rhode Island|
|Principal Investigator:||Edward F. Donovan, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||James A. Lemons, MD||Indiana University|
|Principal Investigator:||Shahnaz Duara, MD||University of Miami|
|Principal Investigator:||Charles R. Rosenfeld, MD||University of Texas, Southwestern Medical Center at Dallas|
|Principal Investigator:||Jon E. Tyson, MD MPH||The University of Texas Health Science Center, Houston|
|Principal Investigator:||Seetha Shankaran, MD||Wayne State University|
|Principal Investigator:||Richard A. Ehrenkranz, MD||Yale University|
|Principal Investigator:||T. Michael O'Shea, MD MPH||Wake Forest University|
|Principal Investigator:||Neil N. Finer, MD||University of California, San Diego|
|Principal Investigator:||Dale L. Phelps, MD||University of Rochester|
|Principal Investigator:||Mark L. Hudak, MD||University of Florida|
|Principal Investigator:||Robin H. Steinhorn, MD||Northwestern University|
|Principal Investigator:||G. Ganesh Konduri, MD||Medical College of Wisconsin, Milwaukee|
Publications of Results:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Inhaled nitric oxide
Idiopathic pulmonary hypertension
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Endothelium-Dependent Relaxing Factors