Respiratory Outcome at Adolescence of Very Low Birthweight Infants (EPIPAGEADO)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Premature Baby 26 to 32 Weeks

Bronchopulmonary Dysplasia

Treatments

Other: Prevention and follow-up of the patients pulmonary parameters

Study type

Interventional

Funder types

Other

Identifiers

NCT01424553

P100117

Details and patient eligibility

About

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.

Full 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.

Enrollment

355 patients

Sex

All

Ages

14 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 :