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

Primary Purpose

Premature Baby 26 to 32 Weeks, Bronchopulmonary Dysplasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prevention and follow-up of the patients pulmonary parameters
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Baby 26 to 32 Weeks focused on measuring Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma

Eligibility Criteria

14 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Necker

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort

Arm Description

All patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary parameters
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.
Standardized questionnaire for respiratory symptoms
Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)

Full Information

First Posted
August 22, 2011
Last Updated
April 20, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01424553
Brief Title
Respiratory Outcome at Adolescence of Very Low Birthweight Infants
Acronym
EPIPAGEADO
Official Title
Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Baby 26 to 32 Weeks, Bronchopulmonary Dysplasia
Keywords
Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Other
Arm Description
All patients
Intervention Type
Other
Intervention Name(s)
Prevention and follow-up of the patients pulmonary parameters
Other Intervention Name(s)
Prevention and follow-up pulmonary parameters
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced expiratory volume
Description
Forced expiratory volume in one seconde (FEV1) at 14-15 years
Time Frame
Day 0 (at 14 - 15 years old)
Secondary Outcome Measure Information:
Title
Pulmonary parameters
Description
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.
Time Frame
Day 0 (at 14 - 15 years old)
Title
Standardized questionnaire for respiratory symptoms
Time Frame
Day 0 (at 14-15 years old)
Title
Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)
Time Frame
Day 0 (at 14-15 years old)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Delacourt, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29605813
Citation
Hadchouel A, Rousseau J, Roze JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Verstraete M, Ancel PY, Delacourt C; EPIPAGEADO study group. Association between asthma and lung function in adolescents born very preterm: results of the EPIPAGE cohort study. Thorax. 2018 Dec;73(12):1174-1176. doi: 10.1136/thoraxjnl-2017-211115. Epub 2018 Mar 31.
Results Reference
derived

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Respiratory Outcome at Adolescence of Very Low Birthweight Infants

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