[Focus on the Odon Device™: Technical improvements, mechanical principles and progress of the clinical research program]. / Mise au point sur l'Odon Device™ : amélioration technique, fonctionnement et avancée du programme de recherche clinique.

The Odon Device™ has been described in the literature since 2013 and the World Health Organization supports its development through the Human Reproduction Program. This innovative device could be easier to use than usual instruments and could be an alternative to caesarean section during the second stage of labor, especially in countries where access to obstetric care is limited. The aim of the Odon Device™ is to position an air cuff over the fetal head, past its widest point (around the level of the fetal mouth anteriorly and the nape of the fetal neck posteriorly). Three mechanical principles favor the progression of the fetal head with the Odon Device™: partial propulsion, limited flexion and traction. Preliminary clinical studies on animals and simulators are reassuring and show that an appropriate use is no more at risk than the vaccum or forceps. A phase 1 study was conducted in Argentina and South Africa between 2011 and 2017. The reported failure rate was 29%, of which 77% was secondary to a mechanical failure of one of the components of the device. Improvements concerning the applicator, the handles and the inflatable air cuff have been made to the device. Phase II of the clinical research program began in 2018 and includes two studies in two different centers: The ASSIST Study in Bristol, England, and The BESANCON ASSIST Study, Besançon, France.

Extremely premature infants: How does death in the delivery room influence mortality rates in two level 3 centers in France?

OBJECTIVES: Mortality rates of very preterm infants may vary considerably between healthcare facilities depending on the neonates' place of inclusion in the cohort study. The objective of this study was to compare the mortality rates of live-born extremely preterm neonates observed in two French tertiary referral hospitals, taking into account the occurrence of neonatal death both in the delivery room and in the neonatal intensive care unit (NICU). METHODS: Retrospective observational study including all pregnancy terminations, stillbirths and live-born infants within a 22- to 26-week 0/6 gestational age range was registered by two French level 3 university centers between 2009 and 2013. The mortality rates were compared between the two centers according to two places of inclusion: either the delivery room or the NICU. RESULTS: A total of 344 infants were born at center A and 160 infants were born at center B. Among the live-born neonates, the rates of neonatal death were similar in center A (54/125, 43.2%) and center B (33/69, 47.8%; P=0.54). However, neonatal death occurred significantly more often in the delivery room at center A (31/54, 57.4%) than at center B (6/33, 18.2%; P<0.001). Finally, the neonatal death rate of live-born very preterm neonates admitted to the NICU was significantly lower in center A (25/94, 26.6%) than in center B (27/63, 42.9%; P=0.03). CONCLUSIONS: This study points out how the inclusion of deaths in the delivery room when comparing neonatal death rates can lead to a substantial bias in benchmarking studies. Center A and center B each endorsed one of the two models of preferential place of neonatal death (delivery room or NICU) detailed in European studies. The reasons behind the two different models and their impact on how parents perceive supporting their neonate need further investigation.