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

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ClinicalTrials.gov Identifier: NCT01424553
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia Other: Prevention and follow-up of the patients pulmonary parameters Not Applicable

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  (Clinical Trial)
Actual Enrollment : 355 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
Study Start Date : October 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Arm Intervention/treatment
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 Name: Prevention and follow-up pulmonary parameters



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424553


Locations
France
Hopital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christophe Delacourt, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01424553     History of Changes
Other Study ID Numbers: P100117
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Low birthweight
Bronchopulmonary dysplasia
Lung development
Airway obstruction
Asthma

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Birth Weight
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight
Signs and Symptoms