Bronchopulmonary Dysplasia, Premature Baby 26 to 32 Weeks
Conditions
Keywords
Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma
Brief summary
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
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.
Interventions
OTHERPrevention and follow-up of the patients pulmonary parameters
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.
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume | Day 0 (at 14 - 15 years old) | Forced expiratory volume in one seconde (FEV1) at 14-15 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD) | Day 0 (at 14-15 years old) | — |
| Pulmonary parameters | Day 0 (at 14 - 15 years old) | 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. |
| Standardized questionnaire for respiratory symptoms | Day 0 (at 14-15 years old) | — |
Countries
France
Outcome results
None listed