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

Determine the level of melatonin production of the premature newborn and evaluate its protective effect in the cerebral growth.

PROJECT LEADERS

Dr Pierre Gressens, Director of Research Inserm, Director of UMR 676 , University of Paris Diderot, Assistant- Director of the PremUp Foundation.
Pr Corinne Alberti, Professor of Epidemiology, Director of the Epidemiological Unit.
Pr Olivier Baud, Professor of Neonatology and Director of an Inserm Avenir team.
Dr Valérie Biran, Neonatologist.

Context

The brain of the premature baby is an extremely vulnerable organ as it is still immature at this stage of gestation and very susceptible to inflammation. It can also suffer repercussions of the lack of oxygen frequently experienced by the premature newborn during the birth process and the first few days of life. The neurological record of the premature newborn unfortunately provides little information. It is only later that problems in learning to walk, in language acquisition, behaviour, sight, hearing, and school progress become apparent.
In a societal context where prematurity is common and increasing all the time, there is an urgent need to find new therapeutic targets to protect the brain.

Objectives

  • Determine the level of melatonin production of the premature newborn so as to determine the extent of the deficiency in premature babies.
  • Do clinical trials of premature babies at high risk of cerebral lesions to evaluate the protective effect of melatonin, which has already been successfully tested by PremUp researchers on appropriate
    pre-clinical models.


Added value of PremUp foundation

A great advantage of PremUp at the preclinical level is that it brings together teams acknowledged to be international leaders both in the domain of research into the mechanism of cerebral lesions in the premature and research into new forms of medication for protecting this extremely vulnerable brain. Most significantly, these teams have discovered that melatonin can protect the immature brain. The other great advantage of PremUp is that it can provide carry out a comprehensive range of research, from "the mattress to the incubator", by making use of a clinical network that includes the departments of obstetrics and neonatology of the 3 level III perinatal centres in the Paris area, a technical capacity for technologically advanced imaging and structures dedicated to the transfer of pre-clinical research to clinical trials.

Projected budget

Budget over 3 years Year 1 Year 2 Year 3 TOTAL
Melatonin 30.000 30.000 60.000
Dosage kits 60.000 60.000 60.000 180.000
Clinical research assistant 50.000 50.000 50.000 150.000

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

 5.500 7.000 7.000 19.500
115.500 147.000 147.000 409.500

  • 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