Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001307796
Ethics application status
Approved
Date submitted
13/07/2022
Date registered
10/10/2022
Date last updated
10/10/2022
Date data sharing statement initially provided
10/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of newborn infants with stomas. To assess complications and death rates after stoma formation as well as the reasons for stoma formation and the timing of stoma closure.
Scientific title
Rates of Morbidity and Mortality Associated with Neonatal Stomas. A prospective observational study to assess morbidity and mortality after neonatal stoma formation, in addition to indications and timing of closure.
Secondary ID [1] 307557 0
None
Universal Trial Number (UTN)
Trial acronym
ROMANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Necrotising enterocolitis 327002 0
Malrotation midgut volvulus 327003 0
Meconium ileus 327004 0
Milk curd obstruction 327005 0
Intestinal atresia 327006 0
Hirschsprung disease 327007 0
Anorectal malformation 327008 0
Condition category
Condition code
Surgery 324186 324186 0 0
Other surgery
Inflammatory and Immune System 324187 324187 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 324188 324188 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Reproductive Health and Childbirth 324552 324552 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure group = infants </=30 days corrected gestational age undergoing surgery and formation of a gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period). Information collected includes demographics, clinical status, operation performed and any complications. No active involvement of participants: all data collected from medical records. Period of observation is 3-month period September-November 2022, with a 3-month follow-up period December 2022 – February 2023
Intervention code [1] 324020 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332001 0
Mortality. Collected from hospital records
Timepoint [1] 332001 0
3 months from recruitment.
Secondary outcome [1] 411874 0
Morbidity. Collected from hospital records
Timepoint [1] 411874 0
3 months from recruitment
Secondary outcome [2] 411875 0
Closure of stoma. Collected from hospital records.
Timepoint [2] 411875 0
3 months following stoma formation. Collected from hospital records

Eligibility
Key inclusion criteria
All new neonatal gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period
Minimum age
No limit
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
>30 days' corrected gestational age and infants without stomas

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using Prism (GraphPad Software, San Diego, CA; USA). Data will be screened for duplicates and these removed. Missing data for co-variates will be dealt with by running a) complete case analysis and b) using multiple imputation to allow inclusion of cases with missing data.
A formal power calculation was not performed for this observational study due to the rates of complications and practice in Australia and New Zealand being unknown and the goal of characterising practice and outcomes here. Based on published case series and the number of centres involved, the expected cohort would total approximately 50 infants.
Summary statistics for the demographic data will be calculated, i.e. median and interquartile range for birthweight, weight at operation, gestational age, corrected age at operation, type of stoma for each indication, median longevity of stomas closed during the study period).

Significant differences in complications between indications will not be calculated as this would likely represent an oversimplification – any differences could well be explained by confounders such as gestational age and birthweight (e.g., NEC patients likely to have lower gestational age and weight compared with those with Hirschsprung disease).

Multivariate logistic regression will therefore be performed between each complication and the covariates listed under patient factors, surgical disease factors and operation factors. Coefficients with a p-value of <0.05 will be considered significant, but all will be tabulated.

No comparisons will be made between individual hospitals, states or countries due to small numbers expected at some centres.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 22803 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 22804 0
Westmead Hospital - Westmead
Recruitment hospital [3] 22806 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 22807 0
Mater Women's & Children's Private Health Services - South Brisbane
Recruitment hospital [5] 22808 0
Monash Children’s Hospital - Clayton
Recruitment hospital [6] 22809 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [7] 22811 0
Townsville University Hospital - Douglas
Recruitment hospital [8] 22812 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38090 0
2145 - Westmead
Recruitment postcode(s) [2] 38094 0
3052 - Parkville
Recruitment postcode(s) [3] 38093 0
3168 - Clayton
Recruitment postcode(s) [4] 38092 0
4101 - South Brisbane
Recruitment postcode(s) [5] 38096 0
4814 - Douglas
Recruitment postcode(s) [6] 38089 0
5006 - North Adelaide
Recruitment postcode(s) [7] 38097 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 24893 0
New Zealand
State/province [1] 24893 0
Auckland, Waikato, Wellington & Christchurch

Funding & Sponsors
Funding source category [1] 311832 0
Other Collaborative groups
Name [1] 311832 0
ANZSCRAFT
Country [1] 311832 0
Australia
Primary sponsor type
Individual
Name
Timothy Little
Address
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 313308 0
Individual
Name [1] 313308 0
Kiera Roberts
Address [1] 313308 0
Women's & Children's Hospital
72 King William St, Adelaide SA 5000, Australia
Country [1] 313308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311274 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 311274 0
72 King William St, Adelaide SA 5000, Australia
Ethics committee country [1] 311274 0
Australia
Date submitted for ethics approval [1] 311274 0
03/06/2022
Approval date [1] 311274 0
20/07/2022
Ethics approval number [1] 311274 0
2022/HRE00132
Ethics committee name [2] 311275 0
AHREC
Ethics committee address [2] 311275 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Ethics committee country [2] 311275 0
New Zealand
Date submitted for ethics approval [2] 311275 0
15/07/2022
Approval date [2] 311275 0
Ethics approval number [2] 311275 0

Summary
Brief summary
Stoma formation in the neonatal period is necessary in many surgical conditions. There remains debate surrounding a number of factors (such as indications, type, timing of closure) and a paucity of quality literature to inform these decisions.
The study aims to give an accurate reflection of practice and outcomes in Australia and New Zealand. Results will be used to aid and improve decision-making for this vulnerable group of patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120534 0
Dr Timothy Little
Address 120534 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 120534 0
New Zealand
Phone 120534 0
+64 93670000
Fax 120534 0
Email 120534 0
tlittle@adhb.govt.nz
Contact person for public queries
Name 120535 0
Dr Timothy Little
Address 120535 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 120535 0
New Zealand
Phone 120535 0
+64 93670000
Fax 120535 0
Email 120535 0
tlittle@adhb.govt.nz
Contact person for scientific queries
Name 120536 0
Dr Timothy Little
Address 120536 0
Starship Children's Hospital
2 Park Road
Grafton
Auckland 1023
Country 120536 0
New Zealand
Phone 120536 0
+64 93670000
Fax 120536 0
Email 120536 0
tlittle@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small numbers and concerns for individuals being identifiable


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16613Study protocol    384369-(Uploaded-13-07-2022-20-38-43)-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
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