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 ('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 of neonatal patients with double enterostomies.

Molecular breeding of transgenic white clover (Trifolium repens L.) with field resistance to Alfalfa mosaic virus through the expression of its coat protein gene.

Viral diseases, such as Alfalfa mosaic virus (AMV), cause significant reductions in the productivity and vegetative persistence of white clover plants in the field. Transgenic white clover plants ectopically expressing the viral coat protein gene encoded by the sub-genomic RNA4 of AMV were generated. Lines carrying a single copy of the transgene were analysed at the molecular, biochemical and phenotypic level under glasshouse and field conditions. Field resistance to AMV infection, as well as mitotic and meiotic stability of the transgene, were confirmed by phenotypic evaluation of the transgenic plants at two sites within Australia. The T(0) and T(1) generations of transgenic plants showed immunity to infection by AMV under glasshouse and field conditions, while the T(4) generation in an agronomically elite 'Grasslands Sustain' genetic background, showed a very high level of resistance to AMV in the field. An extensive biochemical study of the T(4) generation of transgenic plants, aiming to evaluate the level and composition of natural toxicants and key nutritional parameters, showed that the composition of the transgenic plants was within the range of variation seen in non-transgenic populations.