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

Weight gain following the adoption of the chyme recycling technique in neonates with a high output stoma.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000835842
Enrollment
20
Registered
2021-06-30
Start date
2022-02-09
Completion date
2025-10-04
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some newborns present with a rare condition called intestinal failure, which often requires a temporary stoma. With the aim of reducing complications associated with the type of nutritional support offered to these patients, a novel protocol has been proposed. It consists of reinfusing enteric content back to the bowel. We hypothesise this technique will enable newborns to gain weight, reduce infections, and shorten the length of their NICU stay.

Interventions

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 f

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.

Sponsors

The Insides Company
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 3 Months
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026