Respiratory Outcome at Adolescence of Very Low Birthweight Infants (EPIPAGEADO)
This study is currently recruiting participants.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01424553
First received: August 22, 2011
Last updated: July 25, 2012
Last verified: June 2011
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Purpose
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 | Intervention |
|---|---|
|
Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia |
Other: Prevention and follow-up of the patients pulmonary parameters |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Forced expiratory volume [ Time Frame: Day 0 (at 14 - 15 years old) ] [ Designated as safety issue: No ]Forced expiratory volume in one seconde (FEV1) at 14-15 years
Secondary Outcome Measures:
- Pulmonary parameters [ Time Frame: Day 0 (at 14 - 15 years old) ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0 (at 14-15 years old) ] [ Designated as safety issue: No ]
- Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD) [ Time Frame: Day 0 (at 14-15 years old) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 15 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424553
Contacts
| Contact: Christophe Delacourt, MD, PhD | 0033144494955 | christophe.delacourt@nck.aphp.fr |
| Contact: Raphaël Serreau, MD, PhD | 0033158411180 | raphael.serreau@cch.aphp.fr |
Locations
| France | |
| Hopital Necker | Recruiting |
| Paris, France, 75015 | |
| Contact: Christophe delacourt, MD, PhD +331444949 55 christophe.delacourt@nck.aphp.fr | |
| Contact: Laurence Lecomte, PhD +33158413545 laurence.lecomte@ch.aphp.fr | |
| Principal Investigator: Christophe Delacourt, MD, PhD | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Christophe Delacourt, MD, PhD | AP-HP |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01424553 History of Changes |
| Other Study ID Numbers: | P100117 |
| Study First Received: | August 22, 2011 |
| Last Updated: | July 25, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Low birthweight Bronchopulmonary dysplasia Lung development Airway obstruction Asthma |
Additional relevant MeSH terms:
|
Birth Weight Bronchopulmonary Dysplasia Body Weight Signs and Symptoms Ventilator-Induced Lung Injury |
Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 23, 2013