Infectious disease in premature newborn babies

Context

Prescribing medications that have no marketing authorization is frequent in paediatrics, reported to occur in more than 90% of babies in neonatal intensive care. It is an important therapeutic issue as this situation deprives preterm and term newborns of possible therapeutic progresses or exposes them to increased risks of ineffectiveness or toxicity. Moreover, medications are often available in galenic forms that are not adapted to newborns entailing the risk of administration errors.
Infection represents a real danger for the full term and premature newborn, as it may result in serious neonatal sequaelae. Paediatricians have a great expertise in the use of many drugs, including antibiotics, some of them being widely prescribed. Nevertheless, knowledge remains limited and there is often a lack of data related to optimal dosage, or potential risks, that are major for the management the premature.
Evaluation of the antibiotics in the newborn is thus inadequate. Additional knowledge is required to validate dosage, taking into account many parameters such as the clinical situation, gestation age at delivery, weight, organ immaturity (liver and kidneys). Indeed, it is only by adjusting dosage and evaluating the risk to benefit ratio of antibiotics that infections in premature and term babies can be effectively treated.

Objectives

• Create a data base on already available data on the pharmacology and use of antibiotics preterm and term neonates, available for clinicians of the 3 perinatal centres of the level 3 PremUp network. This will allow to collect and analyse informations on the administration of antibiotics to the premature and term newborns. At a later stage accessibility may be extended to other prenatal centres.
• Centralise pharmacokinetic information on antibiotics available in the centres, analyse it to define parameters impacting their use, synthesize existing information and recommendations for better prescription and make this available to departments of neonatology.
• Extend this method to other classes of drugs once this study has proved its utility.

Added value of PremUp Foundation

PremUp's care facility includes the most extensive perinatal activity in the Ile de France region and the management of more than 8.000 premature babies per year: this guarantees that it has the capacity to carry out clinical studies based on data of high quality and sufficient quantity to be rapidly utilised.

Projected budget