Respiratory Outcome at Adolescence of Very Low Birthweight Infants

Bronchopulmonary Dysplasia Clinical Trial

— EPIPAGEADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424553
• Other study ID #: P100117
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: April 20, 2015
• Start date: October 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 15 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Premature Baby 26 to 32 Weeks

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume	Forced expiratory volume in one seconde (FEV1) at 14-15 years	Day 0 (at 14 - 15 years old)	No
Secondary	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.	Day 0 (at 14 - 15 years old)	No
Secondary	Standardized questionnaire for respiratory symptoms		Day 0 (at 14-15 years old)	No
Secondary	Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)		Day 0 (at 14-15 years old)	No