Respiratory Outcome at Adolescence of Very Low Birthweight Infants (EPIPAGEADO)
|Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia||Other: Prevention and follow-up of the patients pulmonary parameters|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort|
- Forced expiratory volume [ Time Frame: Day 0 (at 14 - 15 years old) ]Forced expiratory volume in one seconde (FEV1) at 14-15 years
- Pulmonary parameters [ Time Frame: 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 [ Time Frame: Day 0 (at 14-15 years old) ]
- Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD) [ Time Frame: Day 0 (at 14-15 years old) ]
|Study Start Date:||October 2011|
|Study Completion Date:||April 2015|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Other: Prevention 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.
Other Name: Prevention and follow-up pulmonary parameters
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424553
|Paris, France, 75015|
|Principal Investigator:||Christophe Delacourt, MD, PhD||Assistance Publique - Hôpitaux de Paris|