Respiratory Outcome at Adolescence of Very Low Birthweight Infants

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 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

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