Inhaled Nitric Oxide and Neuroprotection in Premature Infants

Bronchopulmonary Dysplasia Clinical Trial

— NOVA2  

Official title:

Inhaled Nitric Oxide and Neuroprotection in Premature Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00515281
• Other study ID #: 15405A
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: May 2008
• Est. completion date: June 7, 2023

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 484
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hemorrhage
• Intraventricular Hemorrhage
• Leukomalacia, Periventricular
• Periventricular Leukomalacia
• Premature Birth
• Prematurity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mestan KK, Marks JD, Hecox K, Huo D, Schreiber MD. Neurodevelopmental outcomes of premature infants treated with inhaled nitric oxide. N Engl J Med. 2005 Jul 7;353(1):23-32. doi: 10.1056/NEJMoa043514. — View Citation

Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003 Nov 27;349(22):2099-107. doi: 10.1056/NEJMoa031154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopment		Two years
Primary	Bronchopulmonary dysplasia		36 weeks of age corrected
Secondary	Severe IVH / PVL		40 weeks of age corrected