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Completed

NCT Number: NCT00390065

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maternite Regionale Universitaire, Nancy, France

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About this study

Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All infants included at birth in a randomized controlled trial using early nitric oxide therapy

Exclusion criteria

  • Parental refusal

Treatment and study plan

nitric oxide

Drug

Early low dose (5ppm) NO inhalation Placebo

Other names: Reference group (non hypoxemic infants)

Primary outcomes

  1. Pulmonary Function testing

    Time frame: at 7 years postnatal age

Secondary outcomes

  1. Neurodevelopmental and Cognitive outcomes

    Time frame: at 7 years of age

Sponsors and collaborators

Lead sponsor

Maternite Regionale Universitaire

Other

Registry information

Official study title

Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2006
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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