Overview

This trial is active, not recruiting.

Conditions prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia
Treatments inhaled nitric oxide, oxygen
Phase phase 2/phase 3
Sponsor University of Chicago
Start date May 2008
End date January 2016
Trial size 484 participants
Trial identifier NCT00515281, 15405A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age.
inhaled nitric oxide INO
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.
(Placebo Comparator)
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
inhaled nitric oxide INO
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 O2
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.

Primary Outcomes

Measure
Neurodevelopment
time frame: Two years
Bronchopulmonary dysplasia
time frame: 36 weeks of age corrected

Secondary Outcomes

Measure
Severe IVH / PVL
time frame: 40 weeks of age corrected

Eligibility Criteria

Male or female participants up to 72 hours old.

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

Additional Information

Official title Inhaled Nitric Oxide and Neuroprotection in Premature Infants
Principal investigator Michael D. Schreiber, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Chicago.