View Clinical Trial (Medical Research Study)
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Prematurity - Bronchopulmonary Dysplasia - Intraventricular Hemorrhage - Periventricular Leukomalacia |
| Purpose: |
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The purpose of this study is to determine whether inhaled nitric oxide improves the
neurological outcome for premature infants.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00515281 |
| Primary Contact: |
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Principal Investigator
Michael D. Schreiber, M.D.
University of Chicago
Ivana Brajkovic
Phone: 773-702-6210 ext. 4-1730
Email: ibrajkov@peds.bsd.uchicago.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60637
United States
Ivana Brajkovic
Phone: 773-702-6210
Email: ibrajkov@peds.bsd.uchicago.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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