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NCT Number: NCT01424553

Respiratory Outcome at Adolescence of Very Low Birthweight Infants

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.

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Key information

Conditions

Premature Baby 26 to 32 Weeks Airway Obstruction Asthma Bronchial Diseases Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Diseases, Obstructive Lung Injury Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

14 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention and follow-up of the patients pulmonary parameters

Other

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

Primary outcomes

  1. Forced expiratory volume

    Time frame: Day 0 (at 14 - 15 years old)

    Forced expiratory volume in one seconde (FEV1) at 14-15 years

Secondary outcomes

  1. 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.

  2. Standardized questionnaire for respiratory symptoms

    Time frame: Day 0 (at 14-15 years old)

  3. Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)

    Time frame: Day 0 (at 14-15 years old)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: EPIPAGEADO

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Aug 29, 2011
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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