NCT01424553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

August 22, 2011

Last Update Submit

September 1, 2025

Conditions

Premature Baby 26 to 32 WeeksBronchopulmonary Dysplasia

Keywords

Low birthweightBronchopulmonary dysplasiaLung developmentAirway obstructionAsthma

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume

    Forced expiratory volume in one seconde (FEV1) at 14-15 years

    Day 0 (at 14 - 15 years old)

Secondary Outcomes (3)

  • Pulmonary parameters

    Day 0 (at 14 - 15 years old)

  • 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)

Study Arms (1)

Cohort

OTHER

All patients

Other: Prevention and follow-up of the patients pulmonary parameters

Interventions

Prevention and follow-up of the patients pulmonary parametersOTHER

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.

Also known as: Prevention and follow-up pulmonary parameters
Cohort

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Severe neurologic impairment, with impossibility of reliable lung function tests
  • Absence of child's or parents' acceptance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker

Paris, 75015, France

Location

Related Publications (4)

  • 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.

    PMID: 26355460BACKGROUND

  • 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.

    PMID: 29605813BACKGROUND

  • 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.

    PMID: 31509594BACKGROUND

  • 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.

    PMID: 31531873BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary DysplasiaAirway ObstructionAsthma

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory InsufficiencyRespiration DisordersBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christophe Delacourt, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 29, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

FR(1)