Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000835842p
Ethics application status
Submitted, not yet approved
Date submitted
7/05/2021
Date registered
30/06/2021
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 304156 0
The Insides Company trial register number ETRR-11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malnutrition 321848 0
high-output stoma 321849 0
intestinal failure 321850 0
Condition category
Condition code
Reproductive Health and Childbirth 319574 319574 0 0
Complications of newborn
Oral and Gastrointestinal 319575 319575 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 319576 319576 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320488 0
Treatment: Devices
Intervention code [2] 320489 0
Treatment: Other
Comparator / control treatment
There will be no control group, The researchers will compare clinical features observed before and the outcomes after the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327434 0
Receipt of enteral nutrition as assessed from hospital records.
Timepoint [1] 327434 0
Enteral nutrition prescriptions assessed daily until discharge from NICU for a maximum of 90 days
Primary outcome [2] 327435 0
Receipt of parenteral nutrition as assessed from hospital records.
Timepoint [2] 327435 0
Parenteral nutrition prescriptions assessed daily until discharge from NICU for a maximum of 365 days
Primary outcome [3] 327436 0
Weight change assessed from hospital records
Timepoint [3] 327436 0
Weight change assessed from hospital records weekly until discharge from NICU for a maximum of 365 days.
Secondary outcome [1] 395126 0
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.
Timepoint [1] 395126 0
enterostomies diameters will be measured once immediately before the reversal procedure.

Eligibility
Key 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.
Minimum age
0 Days
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will consist of a comparison of key clinical features before and after the intervention

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 23679 0
New Zealand
State/province [1] 23679 0
Auckland

Funding & Sponsors
Funding source category [1] 308528 0
Commercial sector/Industry
Name [1] 308528 0
The Insides Company Limited
Country [1] 308528 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Insides Company
Address
487 Parnell Road, Auckland, 1052
Country
New Zealand
Secondary sponsor category [1] 309391 0
None
Name [1] 309391 0
Address [1] 309391 0
Country [1] 309391 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308483 0
Northern B HDEC
Ethics committee address [1] 308483 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308483 0
New Zealand
Date submitted for ethics approval [1] 308483 0
26/01/2021
Approval date [1] 308483 0
Ethics approval number [1] 308483 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110854 0
Mr Andre Modesto
Address 110854 0
The University of Auckland
22-30 Park Avenue, Grafton, Auckland 1023
Country 110854 0
New Zealand
Phone 110854 0
+64 223596027
Fax 110854 0
Email 110854 0
[email protected]
Contact person for public queries
Name 110855 0
Prof Greg O'Grady
Address 110855 0
The University of Auckland
22-30 Park Avenue, Grafton, Auckland 1023
Country 110855 0
New Zealand
Phone 110855 0
+64 274222989
Fax 110855 0
Email 110855 0
[email protected]
Contact person for scientific queries
Name 110856 0
Prof Greg O'Grady
Address 110856 0
The University of Auckland
22-30 Park Avenue, Grafton, Auckland 1023
Country 110856 0
New Zealand
Phone 110856 0
+64 274222989
Fax 110856 0
Email 110856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11605Study protocol    381949-(Uploaded-07-05-2021-09-13-44)-Study-related document.docx
11606Informed consent form    381949-(Uploaded-07-05-2021-09-14-13)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.