Inhaled Nitric Oxide and Neuroprotection in Premature Infants (NOVA2)
Recruitment status was Recruiting
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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 |
- Neurodevelopment [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Bronchopulmonary dysplasia [ Time Frame: 36 weeks of age corrected ] [ Designated as safety issue: No ]
- 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: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (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 |
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| Contact: Ivana Brajkovic | 773-702-6210 ext 4-1730 | ibrajkov@peds.bsd.uchicago.edu |
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Ivana Brajkovic 773-702-6210 ext 4-1730 ibrajkov@peds.bsd.uchicago.edu | |
| Principal Investigator: | Michael D. Schreiber, M.D. | University of Chicago |
More Information
Publications:
| Responsible Party: | Michael D. Schreiber, M.D., The University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00515281 History of Changes |
| Other Study ID Numbers: | 15405A |
| Study First Received: | August 9, 2007 |
| Last Updated: | February 4, 2010 |
| 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:
|
Infant, Premature, Diseases Bronchopulmonary Dysplasia Hemorrhage Leukomalacia, Periventricular Cerebral Hemorrhage Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract 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 May 19, 2013