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Trials / Completed

CompletedNCT01424553

Respiratory Outcome at Adolescence of Very Low Birthweight Infants

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
355 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
14 Years – 15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPrevention and follow-up of the patients pulmonary parametersRespiratory 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.

Timeline

Start date
2011-10-01
Primary completion
2014-11-01
Completion
2015-04-01
First posted
2011-08-29
Last updated
2025-09-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01424553. Inclusion in this directory is not an endorsement.