Respiratory Outcome at Adolescence of Very Low Birthweight Infants

Not Applicable

Completed

• Conditions: Premature Baby 26 to 32 Weeks; Bronchopulmonary Dysplasia
• Interventions: Other: Prevention and follow-up of the patients pulmonary parameters

• Registration Number: NCT01424553
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2011-10
• Primary Completion: 2014-11
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Prevention and follow-up of the patients pulmonary parameters	All patients

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume	Day 0 (at 14 - 15 years old)	Forced expiratory volume in one seconde (FEV1) at 14-15 years

Secondary Outcome Measures

Name	Time	Method
Standardized questionnaire for respiratory symptoms	Day 0 (at 14-15 years old)
Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)	Day 0 (at 14-15 years old)
Pulmonary parameters	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.

Trial Locations

Locations (1)

Hopital Necker; 🇫🇷 Paris, France