Brief Title
Respiratory Outcome at Adolescence of Very Low Birthweight Infants
Official Title
Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
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.
Study Type
Interventional
Primary Outcome
Forced expiratory volume
Secondary Outcome
Pulmonary parameters
Condition
Premature Baby 26 to 32 Weeks
Intervention
Prevention and follow-up of the patients pulmonary parameters
Study Arms / Comparison Groups
Cohort
Description: All patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
355
Start Date
October 2011
Completion Date
April 2015
Primary Completion Date
November 2014
Eligibility Criteria
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
Gender
All
Ages
14 Years - 15 Years
Accepts Healthy Volunteers
No
Contacts
Christophe Delacourt, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01424553
Organization ID
P100117
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Christophe Delacourt, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
April 2015