Inhaled Nitric Oxide and Neuroprotection in Premature Infants



Status:Active, not recruiting
Conditions:Bronchitis, Neurology, Women's Studies
Therapuetic Areas:Neurology, Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:10/14/2018
Start Date:May 2008
End Date:July 2019

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

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.

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
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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