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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Premature Birth

Intervention / Treatment
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* Drug: Nitric Oxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants included at birth in a randomized controlled trial using early nitric oxide therapy Exclusion Criteria: Parental refusal

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Hypoxemic Respiratory Failure treated by Nitric Oxide; | Drug: Nitric Oxide<br>* Early low dose (5ppm) NO inhalation Placebo<br>* Other names: Reference group (non hypoxemic infants);|
| Placebo Comparator: Control<br>Hypoxemic Respiratory Failure control (Placebo); | Drug: Nitric Oxide<br>* Early low dose (5ppm) NO inhalation Placebo<br>* Other names: Reference group (non hypoxemic infants);|
| No Intervention: Reference<br>Reference (Non hypoxemic respiratory failure) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function testing |  | at 7 years postnatal age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental and Cognitive outcomes |  | at 7 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants, Follow-up, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes