Status: Finalised
First registered on:
23/11/2018
Last updated on:
23/11/2018
1. Study identification
EU PAS Register NumberEUPAS26681
Official titleA contemporary description of French newborns' growth using the Efemeris cohort.
Study title acronym
Study typeObservational study
Brief description of the studyReference growth curves are used in current practice to identify children at risk, especially at risk of overweight or obesity. National reference growth curves were published 35 years ago from children born in the 1950s to study growth from birth to adulthood. Additionally, more recent national curves exist to study birth weight and height according to gestational age. The primary objective was to describe anthropometric measurements of French children born in the 2000s and to compare them with the French references.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Details of (Primary) lead investigator
Title Dr
Last name Damase-Michel
First name Christine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201501/01/2015
Start date of data collection01/01/201501/01/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report01/01/201701/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherANSM-PHRC100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 137 Allees Jules
Address line 2
Address line 3
CityToulouse
Postcode31000
CountryFrance
Phone number (incl. country code)33-561145904
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 137 Allees Jules
Address line 2
Address line 3
CityToulouse
Postcode31000
CountryFrance
Phone number (incl. country code)33-561145904
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects77000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The primary objective was to describe anthropometric measurements of French children born in the 2000s and to compare them with the French references.
Are there primary outcomes?Yes
Weight, height, and body mass index (BMI) at birth, 9 months, and 24 months
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
The z-score means based on the French references for weight, height, and body mass index (BMI) at birth, 9 months, and 24 months were calculated.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
A contemporary description of French newborns' growth using the Efemeris cohort. Beau AB, Tauber M, Chollet C, Hurault-Delarue C, Bouilhac C, Montastruc JL, Lacroix I, Damase-Michel C.
Arch Pediatr. 2017 May;24(5):424-431.https://www.ncbi.nlm.nih.gov/pubmed/28343882
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
