Respiratory Outcome at Adolescence of Very Low Birthweight Infants (EPIPAGEADO)
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|ClinicalTrials.gov Identifier: NCT01424553|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia||Other: Prevention and follow-up of the patients pulmonary parameters||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||355 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||April 2015|
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
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424553
|Paris, France, 75015|
|Principal Investigator:||Christophe Delacourt, MD, PhD||Assistance Publique - Hôpitaux de Paris|