Very Preterm BirthEPIPAGE2NCT03078439
EPIPAGE2 Cohort Study Follow up at Five and a Half Years
An observational study of Very Preterm Birth, run by Institut National de la Santé Et de la Recherche Médicale, France at 98 sites in 4 countries.
Trial summary
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants… Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Very Preterm Birth
- What is being tested?
- Medical and neuropsychological assessments
- Type of treatment
- Injection or infusion
- How many people
- 3,404 participants
- Where
- 98 sitesin 4 countries
- Study dates
- 2 Sep 2016to 8 Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Preterm children included at birth in the EPIPAGE 2 cohort or in complementary studies whose famillies agree to participate to EPIPAGE 2 follow up (4600 children) + 600 children born at term and participating to the Elfe cohort (French longitudinal study of children)
Who may be able to join
- initially included in EPIPAGE 2 cohort or complementary studies or Elfe cohort study
- family agreement to participate to cohort follow up
- informed consent form signed by both parents
- affiliated to social security system
Who cannot join
- parental refusal
- not affiliated to any social security system
Trial locations and contacts
98 sites in 4 countries.
98 sites in 4 countries
France92 sites
Centre Hopsitalier d'Agen
Agen, 47000
CAMSP Albi
Albi, 82000
CHU Amiens
Amiens, 80000
CHU d'Angers
Angers, 49933
CH d'Arras
Arras, 62022
CAMSP Auch
Auch, 32000
Centre Hospitalier Côte Basque
Bayonne, 64100
CH Beauvais
Beauvais, 40319
CHU Jean Minjoz
Besançon, 25030
Centre Hospitalier de Bordeaux
Bordeaux, 33000
CH Bourg en Bresse
Bourg-en-Bresse, 01012
CHU de Brest
Brest, 29609
Rezo Camsp
Brioude, 43100
Hopital Femme, Mère, Enfant
Bron, 69677
CHU de Caen
Caen, 14000
CH Cahors
Cahors, 46000
CMPP de Cahors
Cahors, 46000
CH de Calais
Calais, 62107
CH de Carcassonne
Carcassonne, 11000
CH Castres - Hôpital du pays d'Autan
Castres, 81100
CH Chalon sur Saone - William Morey
Chalon-sur-Saône, 71100
Réseau Eclaur
Chambéry, 73000
CH Métropole Savoie
Chambéry, 73011
CAMSP de Charleville Mézières
Charleville-Mézières, 08100
CHU Estaing
Clermont-Ferrand, 63000
Centre Hospitalier de Colmar
Colmar, 68024
CH Compiègne
Compiègne, 60200
CH Alpes Leman
Contamine-sur-Arve, 74130
CH Sud Francilien
Corbeil, 91106
CH Creil
Creil, 60109
CAMSP de Dax
Dax, 40100
CHU Dijon - Hôpital du Bocage
Dijon, 21079
CH de Douai
Douai, 59507
Hôpital d'Epinal
Épinal, 88021
CAMSP Espaly
Espaly-Saint-Marcel, 43000
SCM Maison de l'enfant
Essey-lès-Nancy, 54270
Hôpital de Forbach
Forbach, 57600
CHU Grenoble / Réseau Naitre et Devenir
Grenoble, 38043
Centre Hospitalier de Haguenau
Haguenau, 67500
CH Laon
Laon, 02100
CHU Le Mans
Le Mans, 72000
CH de Lens
Lens, 62307
Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, 59000
CHRU de Lille
Lille, 59037
Hôpital Mère-Enfant de Limoges
Limoges, 87042
CAMSP, CHU de Lorient
Lorient, 56100
Hopital de la Croix Rousse
Lyon, 69317
CH Mâcon
Mâcon, 71000
CHU Hôpital Nord
Marseille, 13015
CHU de la Conception
Marseille, 13385
CH de Maubeuge
Maubeuge, 59600
Hôpital de Mercy - CHR Metz Thionville
Metz, 57085
CH Annecy Genevois
Metz-Tessy, 74370
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40024
CAMSP "l'Escabelle" Montauban
Montauban, 82000
CH Montauban
Montauban, 82000
GHH Havre - Hôpital Jacque Monod
Montivilliers, 76290
CHU de Montpellier
Montpellier, 34000
CAMSP - CHU Saint-Eloi
Montpellier, 34295
Centre Hospitalier de Mulhouse
Mulhouse, 68100
CHRU de Nancy (Maternité)
Nancy, 54000
CHRU de Nancy (Neuro-pédiatrie)
Nancy, 54000
CHU de Nantes
Nantes, 44093
CHU Hôpital l'Archet
Nice, 06200
CHU de Nimes - Hôpital Caremeau
Nîmes, 30029
CHR Orléans
Orléans, 45000
Hôpital Armand Trousseau
Paris, 75012
CIC Necker
Paris, 75015
Centre Hospitalier de Pau
Pau, 64000
CAMSP de Périgueux
Périgueux, 24016
CHG de Perpignan (CAMSP)
Perpignan, 66046
CHU de Reims / CAMSP
Reims, 51100
CAMSP, CHU de Rennes
Rennes, 35033
CH Rodez - Jacques Puel
Rodez, 12027
CH de Roubaix
Roubaix, 59100
CHU de Rouen - Pavillon Mère et enfant
Rouen, 76000
CAMSP de Saint Brieuc
Saint-Brieuc, 22027
CHU Sud Réunion
Saint-Pierre, 97448
CHU St Etienne / Réseau HELENA
Saint-Priest-en-Jarez, 42270
CH Saint Quentin
Saint-Quentin, 02100
Centre Hospitalier Hautepierre
Strasbourg, 67200
CH de Bigorre
Tarbes, 65000
CAMSP Thionville
Thionville, 57100
Hôpital Bel Air Thionville - CHR Metz Thionville
Thionville, 57100
CHU de Toulouse - Hôpital des enfants
Toulouse, 31059
Clinique Ambroise Paré
Toulouse, 31082
CHRU de Tours -Hôpital Clocheville
Tours, 37044
CAMSP de Troyes
Troyes, 10000
CH Valence
Valence, 26000
CH de Valenciennes
Valenciennes, 59322
CH de Vannes
Vannes, 56000
CH Villefranche sur Saone
Villefranche-sur-Saône, 69655
French Guiana2 sites
CH Andrée Rosemon
Cayenne
CH de l'Ouest Guyanais
Saint-Laurent-du-Maroni
Guadeloupe2 sites
CAMSP Basse-Terre
Basse-Terre
CHU Pointre à Pitre
Les Abymes
Reunion2 sites
CAMSP Nord-ASFA Sainte Clotilde
Saint-Denis
CHU Felix Guyon
Saint-Denis
About this study
Official title: Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).
These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.
At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.
- Conditions
- Very Preterm Birth
- Being tested
- Medical and neuropsychological assessments
- Keywords
- very preterm birth, developmental disorders, health problems, prospective population-based cohort
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical and neuropsychological assessmentsOther
Assessment of health status and development will be performed in specific centers at 5 and a half years. This check-up includes a complete medical examination to look for visual, hearing, motor impairment and health problems, and psychological tests using standardized tools (WPPSI IV ((Wechsler Preschool and Primary Scales Intelligence)) and NEPSY 2 tests) to assess cognitive development of very preterm children.
A parental questionnaire will be fulfilled to investigate family's social conditions, maternal health, autism spectrum disorders (Social Communication Questionnaire), the child's quality of life and behavioral development (Strengths and Difficulties Questionnaire).
What is being measured
The primary outcome is the main question the study is designed to answer.
Health disorders assessed by medical exam
According to gestational age at birth
Measured: 5 years 5 months- 5 years 11 months
Motor disorders assessed by medical exam
According to gestational age at birth
Measured: 5 years 5 months- 5 years 11 months
Cognitive disorders assessed by psychological testing
According to gestational age at birth
Measured: 5 years 5 months- 5 years 11 months
Behavioural disorders by psychological testing
According to gestational age at birth
Measured: 5 years 5 months- 5 years 11 months
Secondary outcomes (3)
Changes in medical practices collected by questionnaire
Measured: 5 years 5 months- 5 years 11 months
Changes in organization of care collected by questionnaire
Measured: 5 years 5 months- 5 years 11 months
Set up a DNA Biobank by saliva samples collection
Measured: 5 years 5 months- 5 years 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start2 Sep 2016
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Very Preterm BirthStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,404 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078439
- Sponsor's protocol ID
- C15-95
- Other IDs
- IDRCB
- Acronym
- EPIPAGE2
- Status last verified
- Aug 2021
- First submitted
- 8 Nov 2016
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Walter-Nicolet E, Marchand-Martin L, Morgan AS, Kaminski M, Benhammou V, Ancel PY, Tourneux P, Pierrat V, Durrmeyer X. Neurodevelopmental outcomes at five years in children born very preterm (24-31 weeks) exposed to opioids with or without midazolam: results from the French nationwide EPIPAGE-2 cohort study. Lancet Reg Health Eur. 2025 Feb 18;52:101242. doi: 10.1016/j.lanepe.2025.101242. eCollection 2025 May.
PubMed 40060937Guellec I, Brunet A, Lapillonne A, Taine M, Torchin H, Favrais G, Gascoin G, Simon L, Heude B, Scherdel P, Kayem G, Delorme P, Jarreau PH, Ancel PY. Birth weight and head circumference discordance and outcome in preterms: results from the EPIPAGE-2 cohort. Arch Dis Child. 2024 May 17;109(6):503-509. doi: 10.1136/archdischild-2023-326336.
PubMed 38408861Coignard M, Marchand-Martin L, Kermorvant-Duchemin E, Cambonie G, Tosello B, Ancel PY, Torchin H, Guellec I. School-age neurodevelopmental outcomes after non-emergency red blood cell transfusions in preterm infants: a propensity score-matched study from the Epipage 2 cohort. Eur J Pediatr. 2026 Jun 9;185(7):482. doi: 10.1007/s00431-026-07137-5.
PubMed 42262600
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years
- ClinicalTrials.gov ID
- NCT03078439
- Acronym / sponsor ID
- EPIPAGE2 / C15-95
- Conditions
- Very Preterm Birth
- Keywords
- very preterm birth, developmental disorders, health problems, prospective population-based cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,404 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).
These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.
At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm children included at birth in the EPIPAGE 2 cohort or in complementary studies whose famillies agree to participate to EPIPAGE 2 follow up (4600 children) + 600 children born at term and participating to the Elfe cohort (French longitudinal study of children)
Key inclusion criteria (4 listed)
- initially included in EPIPAGE 2 cohort or complementary studies or Elfe cohort study
- family agreement to participate to cohort follow up
- informed consent form signed by both parents
- affiliated to social security system
Key exclusion criteria (2 listed)
- parental refusal
- not affiliated to any social security system
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 |
|---|---|---|
| Medical and neuropsychological assessmentsAssessment of health status and development will be performed in specific centers at 5 and a half years. This check-up includes a complete medical examination to look for visual, hearing, motor impairment and health problems, and psychological tests using standardized tools (WPPSI IV ((Wechsler Preschool and Primary Scales Intelligence)) and NEPSY 2 tests) to assess cognitive development of very preterm children. A parental questionnaire will be fulfilled to investigate family's social conditions, maternal health, autism spectrum disorders (Social Communication Questionnaire), the child's quality of life and behavioral development (Strengths and Difficulties Questionnaire). | Other | – |
Primary outcome
Health disorders assessed by medical exam
Time frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Motor disorders assessed by medical exam
Time frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Cognitive disorders assessed by psychological testing
Time frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Behavioural disorders by psychological testing
Time frame: 5 years 5 months- 5 years 11 months
According to gestational age at birth
3 secondary outcomes
Changes in medical practices collected by questionnaire
Time frame: 5 years 5 months- 5 years 11 months
Changes in organization of care collected by questionnaire
Time frame: 5 years 5 months- 5 years 11 months
Set up a DNA Biobank by saliva samples collection
Time frame: 5 years 5 months- 5 years 11 months
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 15 Apr 2026.
- Results publication: PubMed 40060937Walter-Nicolet E, Marchand-Martin L, Morgan AS, Kaminski M, Benhammou V, Ancel PY, Tourneux P, Pierrat V, Durrmeyer X. Neurodevelopmental outcomes at five years in children born very preterm (24-31 weeks) exposed to opioids with or without midazolam: results from the French nationwide EPIPAGE-2 cohort study. Lancet Reg Health Eur. 2025 Feb 18;52:101242. doi: 10.1016/j.lanepe.2025.101242. eCollection 2025 May.
- Results publication: PubMed 38408861Guellec I, Brunet A, Lapillonne A, Taine M, Torchin H, Favrais G, Gascoin G, Simon L, Heude B, Scherdel P, Kayem G, Delorme P, Jarreau PH, Ancel PY. Birth weight and head circumference discordance and outcome in preterms: results from the EPIPAGE-2 cohort. Arch Dis Child. 2024 May 17;109(6):503-509. doi: 10.1136/archdischild-2023-326336.
- Derived from this study: PubMed 42262600Coignard M, Marchand-Martin L, Kermorvant-Duchemin E, Cambonie G, Tosello B, Ancel PY, Torchin H, Guellec I. School-age neurodevelopmental outcomes after non-emergency red blood cell transfusions in preterm infants: a propensity score-matched study from the Epipage 2 cohort. Eur J Pediatr. 2026 Jun 9;185(7):482. doi: 10.1007/s00431-026-07137-5.
- Epipage 2 websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
98 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Preterm Birth, run by Institut National de la Santé Et de la Recherche Médicale, France at 98 sites in 4 countries.
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 4 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in France, French Guiana, Guadeloupe, Reunion. 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?
Health disorders assessed by medical exam (time frame: 5 years 5 months- 5 years 11 months). The study lists 4 primary outcomes in all. 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 NCT03078439, which also lists 3 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 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.