Neonatal Clinical Guideline for Chyme Reinfusion Therapy

Goals of Chyme Reinfusion Therapy

• Growth and weight gain^1-5.
• Reduce/wean off parenteral nutrition (PN) requirements^1-5.
• Normalisation of renal and liver function via reintroduction of GI feeding and increased length of intestine available for absorption^1-5.
• Increase gut maturation and development^1-5.

Definitions

• Chyme (“kʌɪm”)– A pulpy semi-fluid composition of partly digested food, fluid, stomach acid/gastric juices, and digestive enzymes. Chyme is nutrient rich and is readily absorbed in the small intestine, allowing for nutrients and fluid to be absorbed.
• Chyme Reinfusion Therapy (CRT) – The reintroduction of a patient’s chyme into the efferent or distal limb of their small intestine mucous fistula².
• Double Barrel Enterostomy/End Enterostomy with mucus fistula (stoma) – A surgical procedure where the intestine has a diseased portion resected, and the proximal and distal limbs are brought to the skin surface together and secured to create a stoma.
• Loop Enterostomy (stoma) – A surgical procedure where a loop of the small intestine is brought to the skin surface, an opening is created and secured to create astoma.
• Abcarian Enterostomy – A surgical procedure where the intestine has a diseased portion resected, and the proximal limb is brought out with the distal limb but it is partially sutured to the skin with the rest inside the abdomen.
• Parenteral Nutrition (PN) – Nutrition that is administered via an intravenous route to provide a patient with nutrition to sustain life.
• Enteral Nutrition (EN) – Nutrition that is administered directly into the stomach or intestine to provide a patient with nutrition to sustain life. It is generally administered via a nasogastric tube (NG) or orogastric tube (OG).
• Expressed Breast Milk (EBM)/Human breast milk (HBM) – Breast milk from mother or donor that is administered through a NG or OG⁶.

Chyme Reinfusion Therapy Techniques

• Manual CRT –A process of collecting and sieving the patient’s own chyme then manually syringing it into the patient’s downstream (distal) intestine via a feeding tube installed in the intestine. This is an open system, generally performed by nursing staff.
• CRT with The Insides^® Neo – A closed system. Once The Insides^® Neo has been assembled with the ostomy appliance (See IFU-16 The Insides^® Neo Instructions for Use), CRT can be performed.

Healthcare Professional Training

• Health care professionals must receive formal training and be proficient in installation, set up, and troubleshooting of The Insides® They must also have experience managing patients undergoing CRT.
• Training will be provided by the manufacturer for use of The Insides® Neo, with full access to the Training Hub for additional training materials. Found here: https://www.theinsides.co/training-hub/the-insides-neo/home

Indications for use

The Insides® Neo is intended to be used in paediatric patients who have a loop enterostomy, abcarian enterostomy or end enterostomy with mucous fistula allowing access to the distal intestine. The device is intended to act as a conduit to aid the transfer of chyme from an ostomy appliance into a stoma.  The device can be used in a range of environments including hospitals, A&E, and clinics.

Intended Use

The Insides® Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patient’s intestinal tract.

Contraindications

The Insides® Neo is not suitable for patients who:

• Do not have two available stomal openings with proximal and distal intestinal limbs.
• Have started solid foods.
• Have active Clostridium difficile.
• Do not have a carer that can assist in the use of the product.
• Cannot cover their stoma with the specified ostomy appliance.
• Cannot have chyme refed into their distal limb.

Prior to reinfusing with The Insides® Neo

• Read The Insides® Neo Instructions for Use, Including the Warnings. Ensure that a patient clinical risk assessment is carried out.
• Contrast imaging can be used to evaluate the patency of the patient’s distal tract. If patients have potential or suspected intestinal wall defects, CRT is NOT recommended.
• A generic ENFit^TM feeding tube suitable to be used with the patient can be used with The Insides® Neo. The connector must be ENFitTM to be able to work with The Insides® Neo. Suggested sizes are 6 Fr and 8 Fr.
• CRT with The Insides® Neo is a replacement or supplement for PN and EN. As the patient progresses on The Insides® Neo, EBM or HBM delivered via a NG or OG tube, is increased as the source of nutrition for the patient while the PN and EN is reduced.  
• All infective sources must be resolved before starting The Insides® Neo.
• Assess prolapsed or herniated stomas. Patients may be able to use/continue to use The Insides® Neo after careful clinical evaluation, and if a generic ENFit^TM feeding tube can safely be inserted and secured in the distal limb of the stoma.
• Some conditions may preclude chyme being refed into the distal limb:
  • Imperforate anus - The Insides® Neo can only be used to perform CRT once successful dilation of the neo anus is achieved.
  • Hirschsprung’s - The Insides® Neo cannot be used to perform CRT with patients who have suspected Hirschsprung’s disease in the distal limb of their stoma.
  • Feed Intolerance/only tolerating trophic feeds – If a patient can only tolerate trophic feeds (1 ml every 4 hours to keep the distal intestine ‘open’) this is a contraindication until further clinical assessment is undertaken.

Patient Management

Patient management should be carried out as per standard operating procedures at the local clinical institution. The following patient management and assessment guidelines can be used as guidance in treating patients with CRT using The Insides® Neo.

• Rate of Refeeding
  A syringe infusion pump should be used to reinfuse the patient’s chyme via The Insides® Neo. This ensures the reinfusion is controlled and comfortable for the patient. Each patient will have their own tolerance for the rate of refeeding. As a general guide:
  • It is safe to use chyme that has been sitting in the ostomy appliance for up to 12 hours.
    • If bolus reinfusing - chyme that has been sitting in the ostomy appliance for up to 12 hours and is reinfused within the 12-hour window
    • If continuous reinfusion – Chyme that is collected in 6 hours and then reinfused over the following 6 hours, totalling 12 hours.
  • Use The Insides® Neo every 4-6 hours to withdraw chyme from the ostomy appliance. This full syringe is placed into the syringe infusion pump and reinfused over the next 4 – 6 hours.
  • Depending on the patient’s condition, when the patient starts chyme reinfusion with The Insides® Neo, consider reinfusing half of their output for the first day and discarding the other half.
    • ie., if they pass 20 ml of chyme in 4 hours, only reinfuse 10 ml over the next 4 hours.
  • If the patient has a high output and the refeeding rate is approaching 8-10ml/hour, monitor for signs of reflux from the distal mucus fistula. If there is reflux, reduce the refeeding rate so chyme can be absorbed. Discuss a maximum refeeding rate with the clinical team so that chyme reinfusion is optimised for the patient. This may mean some chyme is discarded initially until the patient can tolerate a higher refeeding rate. The refeeding rate should be reviewed regularly. Reflux can be assessed in the following ways:
    • Chyme can be seen flowing back into the ostomy appliance from the distal limb.
    • The volume in the syringe is more than the last time chyme was withdrawn from the ostomy appliance using The Insides® This is due to the refluxed chyme mixing with fresh chyme.

• Monitoring Bowel Movements
  Patients will likely have a bowel movement within the first three days of starting chyme reinfusion with The Insides® Neo. If a bowel movement has not happened within three days, urgent assessment is required.

• Assessment of Pain and Discomfort
  Regular assessment of abdominal distention and discomfort is necessary. This should be completed a minimum of every 4 – 6 hours.

• Ostomy Appliance
  The Insides® Neo couples with a Hollister™ Newborn Pouch “Pouchkins™” or a Coloplast® “SenSura® Mio Baby”. These ostomy appliances must be changed when they leak and The Insides® Neo must be changed at the same time. The Insides® Neo can be used for up to four days.

Safety

• Read The Insides® Neo Instructions for Use.
• Observe and comply with all manufacturer warnings and patient contraindications when using The Insides® Neo.
• If the patient is experiencing pain during installation or use of The Insides® Neo, this is not normal, and a clinical assessment should be performed to evaluate cause. The Insides® Neo may not be suitable.

Clinical Support

• Please refer to the information manuals contained within The Insides® Neo product box and the Training Hub for Frequently Asked Questions and further guidance around The Insides® https://training.theinsides.co/knowledge/the-insides-neo
• Please contact the Clinical team at The Insides Company for specific clinical support. clinical@theinsides.co

Reference

1. Al-Harbi K, Walton JM, Gardner V, Chessell L, Fitzgerald PG. (1999). Mucous fistula refeeding in neonates with short bowel syndrome. J Pediatr Surg., 34(7):1100-1103. doi:10.1016/S0022-3468(99)90575-4
2. Bhat, S., Cameron, N., Sharma, P., Bissett, I. & O’Grady, G. (2020). Chyme recycling in the management of small bowel double enterostomy in pediatric and neonatal populations: A systematic review. Clinical Nutrition ESPEN, 37. 1-8. Doi.org/10.1016/j.clnesp.2020.03.013
3. Haddock CA, Stanger JD, Albersheim SG, Casey LM, Butterworth SA. (2015). Mucous fistula refeeding in neonates with enterostomies. J Pediatr Surg., 50(5):779-782. doi:10.1016/j.jpedsurg.2015.02.041
4. Lau ECT, Fung ACH, Wong KKY, Tam PKH. (2016). Beneficial effects of mucous fistula refeeding in necrotizing enterocolitis neonates with enterostomies. J Pediatr Surg., 51(12):1914-1916. doi:10.1016/j.jpedsurg.2016.09.010
5. Wong KKY, Lan LCL, Lin SCL, Chan AWS, Tam PKH. (2004). Mucous Fistula Refeeding in Premature Neonates With Enterostomies. J Pediatr Gastroenterol Nutr., 39(1):43. doi:10.1097/00005176-200407000-00009
6. Amin, S., Pappas, C., Iyengar, H. and Maheshwari, A. (2013). Short Bowel Syndrome in the Nicu. Perinatol, 40(1). doi: 10.1016/j.clp.2012.12.003

‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.

‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins™‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.

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