The EPIPAGE 2 study

Improving our understanding of long-term outcomes of very preterm babies to improve their care

Project Leaders

Dr Pierre-Yves Ancel, Epidemiologist, Hôpital Tenon, UMR 953 INSERM, University of Pierre et Marie Curie.
Prof. François Goffinet, Professor of Gynecology/Obstetrics, GH Cochin Saint-Vincent de Paul, Director of Research UMR 953 INSERM, University of Paris Descartes.
Dr Laurence Foix-L'Hélias, Paediatrician, Hôpital A. Béclère (Clamart), UMR 953 INSERM, University Pierre et Marie Curie.
Dr Cécile Lebeaux, Paediatrician, UMR 953 INSERM, University Pierre et Marie Curie.
Team EPIPAGE 2 : clinical and research teams of collaborating French regions.

Context

In France, almost 15 000 infants are born very preterm every year and their numbers continue to increase. The EPIPAGE study carried out in France in 1997 demonstrated that in spite of progress in therapy and quality of care, neonatal mortality and morbidity remained very high, as did the incidence of disabilities: nearly 40 % of very preterm children had motor or sensorineural problems or a mental retardation at 5 years of age, that is, 4 times higher than children born at term.
Recent advances in perinatal care have led to an increase in survival rates of very preterm babies, but have also raised questions about their long-term outcomes. It is in this context that a new national study, EPIPAGE 2, will be introduced in 2011 in the 22 regions of metropolitan France: more than 4 000 very preterm children will be included at birth and followed up to the age of twelve.

Objectives

  • To assess the effect of the organisation of care and medical practices on the health and development of very preterm children.
  • To improve our understanding of the causes and consequences of preterm birth :
    • By doing research on genetic predisposition and biological markers relating to the prematurity of the child.
    • By studying the prognostic value of cerebral lesions on the development of children by using cranial ultrasonography and new Magnetic Resonance Imaging techniques.

Added value of the PremUp Foundation

  • By participating in the co-ordination of the EPIPAGE 2 study, the PremUp Foundation will be launching a collaborative multidisciplinary project which is very important in the domain of prematurity.
  • By putting at the disposal of teams of EPIPAGE 2 innovative platforms of medical and biological imaging, a better understanding of the nature of cerebral anomalies and the role of biological markers very will be possible.

Projected budget

Budget over 3 years Year 1 Year 2 Year 3 TOTAL
for coordinating the investigation

Year 1 Year 2 Year 3 TOTAL

Salary of national coordinator

42.000 42.000 42.000 126.000

Salary of regional coordinators
(3 regions)

12.600 61.200 61.200 135.000

Salary of technical assistants
for clinical research

9.000 108.000 108.000 225.000

Administration costs of the project
(5% of the total amount)

3.180 10.560 10.560 24.300
66.780 221.760 221.760

510.300

  • Prevention of respiratory sequellae in premature newborn babies: role of genetics

  • Protection of the brain of the premature newborn : clinical trials on melatonin

  • Medical imaging, a tool in early detection of cerebral lesions in the premature baby

  • Research into the capacity of stem cells to repair cerebral lesions in the premature newborn

  • The lungs of premature babies: research into new anti-inflammatory treatment

  • Infectious disease in premature newborn babies

  • The EPIPAGE 2 study