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

September 1, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort
All patients
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 Names:
  • Prevention and follow-up pulmonary parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced expiratory volume
Time Frame: Day 0 (at 14 - 15 years old)
Forced expiratory volume in one seconde (FEV1) at 14-15 years
Day 0 (at 14 - 15 years old)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (at 14 - 15 years old)
Standardized questionnaire for respiratory symptoms
Time Frame: Day 0 (at 14-15 years old)
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)
Day 0 (at 14-15 years old)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Principal Investigator: Christophe Delacourt, MD, PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimated)

August 29, 2011

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P100117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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