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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01424553
First received: August 22, 2011
Last updated: June 25, 2014
Last verified: June 2014
  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 ]

Enrollment: 355
Study Start Date: October 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424553

Locations
France
Hopital Necker
Paris, France, 75015
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: June 25, 2014
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
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Signs and Symptoms
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 25, 2014