Evaluating the Efficacy and Safety of Neonatal Chyme Reinfusion Therapy: A Feasibility Study using a Novel Medical Device

Objectives Neonatal and pediatric intestinal failure related to enterostomy is an infrequent but burdensome condition associated with substantial morbidity and mortality. This study presents the development and clinical validation of a novel device to resolve these problems, by formalizing a safe and efficient enterostomy chyme reinfusion technique. Methods A novel neonatal chyme reinfusion device was designed and manufactured (termed the ‘The Insides Neo’, The Insides Company, New Zealand), prior to validation in a feasibility study in tertiary neonatal intensive care centres. Neonates with double enterostomy were recruited and commenced on chyme reinfusion therapy using the novel device to test safety, efficacy, tolerability, and usability within nursing workflows. Device and clinical outcomes were recorded along with nursing feedback. Registered under the ANZCTR, identifier no. ACTRN12621000835842p. Results Ten neonates were recruited across two centres, with a median usage duration of 37.5 (range 12-84) days. Following initiation of therapy, rate of weight gain increased from mean 68.8 ± 37.4 to 197 ± 25.0 g/week (p=0.024). Of the 7/10 neonates on PN at commencement of therapy, 4/7 were able to wean and achieve enteral autonomy. All neonates tolerated the device with uniformly positive nursing feedback and minimal time to learn and incorporate the novel device into nursing workflows. There were no device-related adverse events. Conclusions A novel device was developed and validated to be safe and effective at performing chyme reinfusion therapy in neonates. This device is anticipated to improve the clinical care and outcomes neonatal patients with double enterostomies. What is Known Chyme reinfusion is widely accepted and is a standard of care in many centres who care for neonates with double enterostomy’s. The manual application of chyme reinfusion has led to low adoption despite the many benefits. What is New A new device that automates the process of chyme reinfusion that overcomes many of the barriers outlined in the literature. Uniformly positive nursing feedback that streamlines the Neonatal Intensive Care Unit (NICU) workflow.