Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure (Preemie iNO)

This study has been terminated.
(Preliminary results showed increased intraventricular hemorrhage (IVH) in experimental arm)
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00016523
First received: May 14, 2001
Last updated: January 10, 2011
Last verified: September 2010

May 14, 2001
January 10, 2011
January 2001
September 2003   (final data collection date for primary outcome measure)
Death or Bronchopulmonary Dysplasia [ Time Frame: At 36 weeks post-conceptional age ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00016523 on ClinicalTrials.gov Archive Site
  • Intraventricular Hemorrhage Grade III and IV [ Time Frame: At 36 weeks post-conceptional age ] [ Designated as safety issue: Yes ]
  • Days on assisted ventilation [ Time Frame: At 36 weeks post-conceptional age ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  • Retinopathy of prematurity [ Time Frame: At hospital discharge ] [ Designated as safety issue: Yes ]
  • Air leaks [ Time Frame: At 36 weeks post-conceptual age ] [ Designated as safety issue: Yes ]
  • Days on oxygen [ Time Frame: At 36 weeks post-conceptual age ] [ Designated as safety issue: No ]
  • Supplemental oxygen [ Time Frame: At 36 weeks post-conceptual age ] [ Designated as safety issue: No ]
  • Neurodevelopmental outcome [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
    Started at 5 ppm and could be increased to 10 ppm
  • Drug: Placebo
    Started at 5 ppm and could be increased to 10 ppm
  • Experimental: Inhaled Nitric Oxide
    Inhaled Nitric Oxide
    Intervention: Drug: Inhaled nitric oxide
  • Active Comparator: Placebo
    Inhaled Oxygen
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
420
May 2006
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria

  • 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.

or

  • 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.

Exclusion Criteria

  • 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
Both
up to 120 Hours
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016523
NICHD-NRN-0026, U10HD034216, M01RR000032, U10HD027904, U10HD027853, M01RR008084, U10HD027856, M01RR000750, U10HD021397, M01RR016587, U10HD027880, M01RR000070, U10HD040689, M01RR000633, U10HD021373, U10HD021385, U10HD027871, M01RR006022, U10HD040498, M01RR007122, U10HD040461, U10HD040521, M01RR000044
Yes
Krisa P. Van Meurs, MD, Lead Principal Investigator, Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
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 School of Medicine
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP