Respiratory Outcome at Adolescence of Very Low Birthweight Infants

NCT ID: NCT01424553

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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

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Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort

All patients

Group Type OTHER

Prevention and follow-up of the patients pulmonary parameters

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Prevention and follow-up pulmonary parameters

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Delacourt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Necker

Paris, , France

Site Status

Countries

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France

References

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Hadchouel A, Marchand-Martin L, Franco-Montoya ML, Peaudecerf L, Ancel PY, Delacourt C; EPIPAGEADO study group. Salivary Telomere Length and Lung Function in Adolescents Born Very Preterm: A Prospective Multicenter Study. PLoS One. 2015 Sep 10;10(9):e0136123. doi: 10.1371/journal.pone.0136123. eCollection 2015.

Reference Type BACKGROUND
PMID: 26355460 (View on PubMed)

Hadchouel A, Rousseau J, Roze JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Verstraete M, Ancel PY, Delacourt C; EPIPAGEADO study group. Association between asthma and lung function in adolescents born very preterm: results of the EPIPAGE cohort study. Thorax. 2018 Dec;73(12):1174-1176. doi: 10.1136/thoraxjnl-2017-211115. Epub 2018 Mar 31.

Reference Type BACKGROUND
PMID: 29605813 (View on PubMed)

Drummond D, Hadchouel A, Torchin H, Roze JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Vestraete M, Rousseau J, Ancel PY, Delacourt C; EPIPAGEADO study group. Educational and health outcomes associated with bronchopulmonary dysplasia in 15-year-olds born preterm. PLoS One. 2019 Sep 11;14(9):e0222286. doi: 10.1371/journal.pone.0222286. eCollection 2019.

Reference Type BACKGROUND
PMID: 31509594 (View on PubMed)

Drummond D, Hadchouel A, Le Bourgeois M, Roze JC, Marret S, Rousseau J, Ancel PY, Delacourt C. Decreased pulmonary capillary volume in adolescents born very preterm. Acta Paediatr. 2020 Mar;109(3):621-622. doi: 10.1111/apa.15023. Epub 2019 Oct 2. No abstract available.

Reference Type BACKGROUND
PMID: 31531873 (View on PubMed)

Other Identifiers

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P100117

Identifier Type: -

Identifier Source: org_study_id

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