Inhaled Nitric Oxide and Neuroprotection in Premature Infants (NOVA2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00515281
First received: August 9, 2007
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.


Condition Intervention Phase
Prematurity
Bronchopulmonary Dysplasia
Intraventricular Hemorrhage
Periventricular Leukomalacia
Drug: inhaled nitric oxide
Drug: oxygen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inhaled Nitric Oxide and Neuroprotection in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Neurodevelopment [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks of age corrected ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severe IVH / PVL [ Time Frame: 40 weeks of age corrected ] [ Designated as safety issue: No ]

Estimated Enrollment: 484
Study Start Date: May 2008
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INO Treatment
The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.
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
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
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

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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515281

Contacts
Contact: Elizabeth So 773-834-1730 eso@peds.bsd.uchicago.edu
Contact: Michael D Schreiber, MD 773-702-6205 mschreiber@uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Elizabeth So    773-834-1730    eso@peds.bsd.uchicago.edu   
Contact: Michael D Schreiber, MD    773-702-6205    mschreiber@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Michael D. Schreiber, M.D. University of Chicago
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00515281     History of Changes
Other Study ID Numbers: 15405A
Study First Received: August 9, 2007
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
prematurity
nitric oxide
bronchopulmonary dysplasia
intraventricular hemorrhage
periventricular leukomalacia
neurodevelopment

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Hemorrhage
Leukomalacia, Periventricular
Cerebral Hemorrhage
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on August 20, 2014