Respiratory Outcome at Adolescence of Very Low Birthweight Infants

Study Overview
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Brief Summary
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EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

Detailed Description
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EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk factors for persistent symptoms or impaired lung function tests at adolescence, to assess the exercise tolerance in VLBW children and to search for genetic susceptibility markers associated to impaired lung function. The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The study duration will be 36 months the number of centers will be 4 centers in France (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400, including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with birth at term.

Official Title
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Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort

Conditions
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Premature Baby 26 to 32 Weeks, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Other: Prevention and follow-up of the patients pulmonary parameters


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Children born in 1997, and included at birth in the French EPIPAGE cohort Absence of severe neurologic impairment, with impossibility of reliable lung function tests Acceptance of the child and his/her parents Exclusion criteria : Severe neurologic impairment, with impossibility of reliable lung function tests Absence of child's or parents' acceptance

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 15 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort<br>All patients | Other: Prevention and follow-up of the patients pulmonary parameters<br>* Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.<br>* Other names: Prevention and follow-up pulmonary parameters;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume | Forced expiratory volume in one seconde (FEV1) at 14-15 years | Day 0 (at 14 - 15 years old) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary parameters | Pulmonary parameters will be assess by the measure of Vital capacity, total lung capacity, functional residual capacity, forced expiratory flow 25-75%, diffusing capacity for carbon monoxide, diffusing capacity for nitric monoxide, exhaled nitric monoxide, maximal oxygen consumption at exercise. | Day 0 (at 14 - 15 years old) | 
| Standardized questionnaire for respiratory symptoms |  | Day 0 (at 14-15 years old) | 
| Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD) |  | Day 0 (at 14-15 years old) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma