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Trial record 6 of 27 for:    "Periventricular Leukomalacia"

Inhaled Nitric Oxide and Neuroprotection in Premature Infants (NOVA2)

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ClinicalTrials.gov Identifier: NCT00515281
Recruitment Status : Active, not recruiting
First Posted : August 13, 2007
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE August 9, 2007
First Posted Date  ICMJE August 13, 2007
Last Update Posted Date October 12, 2018
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2007)
  • Neurodevelopment [ Time Frame: Two years ]
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks of age corrected ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00515281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2007)
Severe IVH / PVL [ Time Frame: 40 weeks of age corrected ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Official Title  ICMJE Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Brief Summary The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
Detailed Description With the advances in modern neonatal intensive care medicine in the last 20 years, survival of extremely preterm infants weighing less than 1500g (< 3 lbs, 5 oz) has risen markedly. However, with this increased survival has come a marked increase in the number of infants with serious neurodevelopmental disabilities: Premature infants with birth weights less than 1500g who survive to go home are at significant risk for serious neurodevelopmental problems: cognitive and motor delays, blindness, deafness, and cerebral palsy. In a recent randomized, placebo-controlled clinical trial, we assessed whether giving mechanically ventilated preterm infants inhaled nitric oxide gas (iNO) for 1 week after birth decreased the incidence of death and chronic lung disease. An unanticipated outcome of that study (Schreiber et. al. 2003) and a subsequent study of those infants at 2 years of age (Mestan et. al. 2005) was that premature infants treated with inhaled nitric oxide (iNO) have improved neurodevelopmental outcomes and physical growth at 2 years corrected age, compared with placebo-treated infants (Mestan et. al. 2005). INO therapy, therefore, appears to be a new treatment to protect the premature brain during development outside the womb. The overall goal of this application is understand the efficacy of iNO treatment in improving neurodevelopmental outcomes in at-risk premature infants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Prematurity
  • Bronchopulmonary Dysplasia
  • Intraventricular Hemorrhage
  • Periventricular Leukomalacia
Intervention  ICMJE
  • Drug: inhaled nitric oxide
    The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm.
    Other Name: INO
  • Drug: oxygen
    The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation.
    Other Name: O2
Study Arms  ICMJE
  • Experimental: INO Treatment
    The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.
    Intervention: Drug: inhaled nitric oxide
  • Placebo Comparator: INO Control
    INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age
    Interventions:
    • Drug: inhaled nitric oxide
    • Drug: oxygen
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)
484
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2007)
300
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prematurity (birthweight ≤ 1500g, < 31 weeks gestation)
  • Requiring respiratory support
  • Admitted to the NICU at the University of Chicago

Exclusion Criteria:

  • Severe congenital anomalies
  • Genetic syndromes
  • Extremely sick preterm infants requiring very high ventilatory pressures (OI ≥ 20)
  • Premature infants judged by the physician as nonviable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 72 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 NCT00515281
Other Study ID Numbers  ICMJE 15405A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D. Schreiber, M.D. University of Chicago
PRS Account University of Chicago
Verification Date October 2018

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