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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
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE May 14, 2001
First Posted Date  ICMJE May 16, 2001
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE January 2001
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2011)
Death or Bronchopulmonary Dysplasia [ Time Frame: At 36 weeks post-conceptional age ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Death
  • Chronic Lung Disease at 36 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Official Title  ICMJE Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Respiratory Distress Syndrome (RDS)
  • Sepsis
  • Pneumonia
  • Hypertension, Pulmonary
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Inhaled Nitric Oxide
    Inhaled Nitric Oxide
    Intervention: Drug: Inhaled nitric oxide
  • Active Comparator: Placebo
    Inhaled Oxygen
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2011)
420
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
440
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 120 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00016523
Other Study ID Numbers  ICMJE NICHD-NRN-0026
U10HD034216 ( U.S. NIH Grant/Contract )
M01RR000032 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
M01RR016587 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krisa P. Van Meurs, MD, Lead Principal Investigator, Stanford University
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
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
PRS Account NICHD Neonatal Research Network
Verification Date September 2017

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