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Inhaled Nitric Oxide and Neuroprotection in Premature Infants

NCT00515281 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2024-10-17

Study results available
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Summary

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

Conditions

  • Prematurity
  • Bronchopulmonary Dysplasia
  • Intraventricular Hemorrhage
  • Periventricular Leukomalacia

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Michael D. Schreiber, M.D. · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2023-06-07
Completion
2023-11-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515281 on ClinicalTrials.gov