Inhaled Nitric Oxide and Neuroprotection in Premature Infants (NOVA2)

The University of Chicago

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Prematurity; Intraventricular Hemorrhage; Periventricular Leukomalacia; Bronchopulmonary Dysplasia

Treatments: Drug: inhaled nitric oxide; Drug: oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT00515281

15405A

Details and patient eligibility

About

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

Full 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.

Enrollment: 273 patients

Sex: All

Ages: 2 to 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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273 participants in 2 patient groups, including a placebo group

INO Control (Short iNO)

Placebo Comparator group

Description:

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

Treatment:

Drug: inhaled nitric oxide

INO Treatment (Long iNO)

Experimental group

Description:

The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.

Treatment:

Drug: oxygen

Drug: inhaled nitric oxide