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Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely

NCT00390065 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-03-22

No results posted yet for this study

Summary

Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.

Conditions

  • Premature Birth

Interventions

DRUG

Nitric Oxide

Early low dose (5ppm) NO inhalation Placebo

Sponsors & Collaborators

  • Maternite Regionale Universitaire

    lead OTHER

Principal Investigators

  • Jean-Michel HASCOET, MD · University of NANCY, France

  • Isabelle RM HAMON, MD, PhD · Maternite Regionale Universitaire

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • France

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 NCT00390065 on ClinicalTrials.gov