Weight gain in newborns following the adoption of the stoma refeeding technique

• Register: ANZCTR
• Last refreshed on: 5 July 2021
• Main ID: ACTRN12621000835842
• Date of registration: 30/06/2021
• Prospective Registration: Yes
• Primary sponsor: The Insides Company
• Public title: Weight gain in newborns following the adoption of the stoma refeeding technique
• Scientific title: Weight gain following the adoption of the chyme recycling technique in neonates with a high output stoma.
• Date of first enrolment: 01/07/2021
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000835842.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Prof Greg O'Grady

• Name: Prof Greg O'Grady

Key inclusion & exclusion criteria

Inclusion criteria: 1. Neonates with one or more small intestine stomas or entero-atmospheric fistula(s)
2. Sufficient distal tract length able to handle chyme or enteral nutrition
3. Guardian able to understand the risks/benefits of the study as well as giving consent to their children's participation.
Exclusion criteria: 1. Distal obstruction, anastomotic leak
2. Inability to tolerate chyme reinfusion or enteral feeding.
3. Clinical concern for ischaemic gut
4. Inability to safely intubate the distal stoma.
5. Septic or critically unwell patient


Age minimum: Days
Age maximum: 3 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Other diet and nutrition disorders

malnutrition;high-output stoma;intestinal failure;
malnutrition
high-output stoma
intestinal failure

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

Neonates with high-output stomas will be treated with chyme recycling through a standardised protocol. It includes the use of a novel device purposefully designed for this procedure. The device consists of a valve connected to a 5 ml syringe and a stoma bag. The valve will prevent the reinfused chyme from flowing back to the stoma bag. Patients will have their distal stoma limbs catheterised. The Catheter will be used by the clinical team (trained nurses) will reinfuse part of the chyme output from the proximal limb. The goal is to reinfuse as much enteric content as possible. The amount of chyme being discarded will be recorded. Each participant will experience the intervention four to six times a day on average. A secondary outcome that will be studied is the impact of the intervention on distal stoma atrophy, which may reduce anatomical incompatibility, thus reducing complications following the restoration of bowel continuity. This feature may give the rehabilitation characteristic of the device. The study will last for the duration of the neonate stay in the NICU. The adherence to the protocol will be followed by a researcher, who will visit the participants and will be in close contact with the clinical team. If any potential complications possibly from the interventions arise, they will be discontinued. Instead, the patients will be offered the standard treatment which includes chyme recycling using repurposed materials. If they cannot tolerate the procedure, they will be offered parenteral nutrition and the enteral material will be discarded.

Primary Outcome(s)

Receipt of enteral nutrition as assessed from hospital records. [Enteral nutrition prescriptions assessed daily until discharge from NICU for a maximum of 90 days]

Receipt of parenteral nutrition as assessed from hospital records. [Parenteral nutrition prescriptions assessed daily until discharge from NICU for a maximum of 365 days]

Weight change assessed from hospital records [Weight change assessed from hospital records weekly until discharge from NICU for a maximum of 365 days.]

Secondary Outcome(s)

Evaluate distal stoma atrophy by measuring the proximal and distal enterostomy diameters at the time of the stoma reversal procedure. The stomas will be measured in centimetres using a sterile tape measure during the stoma reversal surgery.[enterostomies diameters will be measured once immediately before the reversal procedure. ]

Secondary ID(s)

The Insides Company trial register number ETRR-11

Source(s) of Monetary Support

The Insides Company Limited

Ethics review

Status: Not approved
Approval date:
Contact:

Northern B HDEC