Premature Baby 26 to 32 WeeksEPIPAGEADONCT01424553
Respiratory Outcome at Adolescence of Very Low Birthweight Infants
A study testing Prevention and follow-up of the patients pulmonary parameters in people with Premature Baby 26 to 32 Weeks and Bronchopulmonary Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 15 years
- Conditions the study is for
- Premature Baby 26 to 32 Weeks, Bronchopulmonary Dysplasia
- What is being tested?
- Prevention and follow-up of the patients pulmonary parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Severe neurologic impairment, with impossibility of reliable lung function tests
- Absence of child's or parents' acceptance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
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.
Read the 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.
- Being tested
- Prevention and follow-up of the patients pulmonary parameters
- Keywords
- Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma
- Medical subject headings
- Bronchopulmonary Dysplasia, Airway Obstruction, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention and follow-up of the patients pulmonary parametersOther
Also called Prevention and follow-up 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | All patients Receives: Other: Prevention and follow-up of the patients pulmonary parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume
Forced expiratory volume in one seconde (FEV1) at 14-15 years
Measured: Day 0 (at 14 - 15 years old)
Secondary outcomes (3)
Pulmonary parameters
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.
Measured: Day 0 (at 14 - 15 years old)
Standardized questionnaire for respiratory symptoms
Measured: Day 0 (at 14-15 years old)
Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)
Measured: Day 0 (at 14-15 years old)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature Baby 26 to 32 WeeksStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe Delacourt, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424553
- Sponsor's protocol ID
- P100117
- Acronym
- EPIPAGEADO
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2011
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26355460Hadchouel 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.
PubMed 29605813Drummond 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.
PubMed 31509594Drummond 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.
PubMed 31531873
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
- ClinicalTrials.gov ID
- NCT01424553
- Acronym / sponsor ID
- EPIPAGEADO / P100117
- Keywords
- Low birthweight, Bronchopulmonary dysplasia, Lung development, Airway obstruction, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2011 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Other: Prevention and follow-up of the patients pulmonary parametersAll patients |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Severe neurologic impairment, with impossibility of reliable lung function tests
- Absence of child's or parents' acceptance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention and follow-up of the patients pulmonary parametersAlso: Prevention and follow-up 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. | Other | Cohort |
Primary outcome
Forced expiratory volume
Time frame: Day 0 (at 14 - 15 years old)
Forced expiratory volume in one seconde (FEV1) at 14-15 years
3 secondary outcomes
Pulmonary parameters
Time frame: Day 0 (at 14 - 15 years old)
Standardized questionnaire for respiratory symptoms
Time frame: Day 0 (at 14-15 years old)
Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)
Time frame: Day 0 (at 14-15 years old)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 26355460Hadchouel 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.
- Results publication: PubMed 29605813Hadchouel 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.
- Results publication: PubMed 31509594Drummond 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.
- Results publication: PubMed 31531873Drummond 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.
Related trials for Premature Baby 26 to 32 Weeks
RecruitingPhase 2
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Intestinal Malabsorption
Not yet recruiting
Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time
Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Baby 26 to 32 Weeks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Delacourt, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention and follow-up of the patients pulmonary parameters in people with Premature Baby 26 to 32 Weeks and Bronchopulmonary Dysplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume (time frame: Day 0 (at 14 - 15 years old)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424553, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.