Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000274572
Ethics application status
Approved
Date submitted
2/03/2015
Date registered
23/03/2015
Date last updated
23/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using a Stool Colour Chart in the care of the new-born - A qualitative study
Scientific title
Stool Colour Chart - a qualitative study on its use to improve passive screening for neonatal cholestasis in 0-6 week olds in New Zealand
Secondary ID [1] 286290 0
nil
Universal Trial Number (UTN)
U1111-1165-5111
Trial acronym
SCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal cholestasis 294373 0
Biliary Atresia 294492 0
Condition category
Condition code
Public Health 294687 294687 0 0
Health promotion/education
Reproductive Health and Childbirth 294794 294794 0 0
Complications of newborn
Oral and Gastrointestinal 294795 294795 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After informed consent, the Lead Maternity Carer (LMC) will undertake an initial questionnaire with families will take place, and then a visual reference card with six colour palettes, three normal stool colours and three abnormal acholic stool colours would be given to families of new-borns and the LMC. The LMC would discuss with the families using the Stool Colour Chart (SCC) as a reminder of normal stool colour at the initial visit at home in the first week of life, then again at the check between 2-6 weeks of life. As a final screen, there will be another chance for intervention at the Six Week Check, either with the LMC or Well Child Provider, with direct questioning using the SCC regarding stool colour. The head investigator will undertake a final exit interview with the families and the health professionals will take place inquiring about the usefulness and ease of use of the SCC and education process. If at any stage there is an abnormally coloured stool, the Protocol for Further Testing if SCC Screen Positive will be instigated.

Data Collection Process:
1) Anonymised data collection will take place at time of consent, including demographics of the family, the gravidity and parity of the mother, name of LMC and the likely WCP that will perform the Six Week Check.
2) A questionnaire asking consented caregivers their perception of normal neonatal stool colour will be performed at the start of the intervention.
3) SCC with instructions will be distributed to the families along with their WCTO - My Health Book. The LMC will also have a copy of the SCC for reference. The family will notify the LMC at any stage if the stool colour is abnormal and Protocol for Further Testing will be implemented.
4) First conversation utilising the SCC between the LMC and family will take place within the first week of life to reinforce the normal stool colour and the sign of acholic stools.
5) At the scheduled WCTO assessment by the LMC between 2-6 weeks of age, there is already a list of suggested topics of conversation which include stool colour. At this point the family and LMC should refer to the SCC and ensure there have not been any abnormal stool colours.
a. If this is the final LMC visit, an exit interview with the LMC will be performed seeking qualitative data regarding the utility of the SCC in helping with the education and dialogue with families on normal neonatal stool colours.
6) There will be a Six Week Check by WCP. A final interaction using the SCC will take place between families and the health professional.
a. Practitioners performing the Six Week Check will be interviewed. The Investigator will coordinate with families to ensure the Six Week Check takes place in a timely manner as the window for effective HPE closes rapidly beyond this point.
7) The families will then be interviewed regarding their experiences with the SCC, compliance with SCC led discussions during WCTO interactions and whether this aided or changed their perceptions of normal and abnormal neonatal stool colour. A repeat question regarding the colour or normal neonatal stool will be asked again of all caregivers.
8) Analysis of pre-intervention perceptions of normal stool colour and the post-intervention understanding of acholic stools will be performed. Satisfaction with the SCC as a screening and educational tool will be assessed with interview results with health professionals and families.
Intervention code [1] 291318 0
Early detection / Screening
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294444 0
1) Feasibility of SCC to be incorporated into Well Child Tamariki Ora framework - Proportion of Families and LMC that have used the SCC as part of usual practice during the 1st week check, 2-6 week check and at the 6 week check
Timepoint [1] 294444 0
At 6 weeks after birth.
Primary outcome [2] 294547 0
2) Post-intervention perceptions of normal stool colour compared to the pre-intervention perceptions. At enrolment prior to birth then at 6 weeks after birth using a questionnaire asking what normal infant stool colour is at birth, at 1st week of life, between 2-6 weeks of life.
The questionnaire has seven colour palettes, the six colours used in the SCC (3 normal, 3 acholic) but also one black palette to resemble meconium or melaena. Caregivers are to choose all the colours they believe resemble normal infant stool colour at those 3 ages. Questionnaire is specifically designed for this trial by the Investigator. The colours used from the SCC are validated as representative of normal stool and acholic stool colours, from the Johns Hopkins Stool Color Card. The addition of black is taken from Pantone colour chart to represent meconium or melaena as chosen by the Investigator.
Timepoint [2] 294547 0
Questionnaire at enrolment (before infant's birth) then repeated at 6 weeks of infant's life.
Primary outcome [3] 294548 0
3) Families and health professional review of the SCC and its use for education and passive screening, assessed by interview. Interviews will consist of open-ended questions and answers transcribed and coded for qualitative and thematic data. Data will be analysed using interpretative phenomenological analysis (IPA). IPA is utilised as part of the recognition that having a new-born is already an event of great adjustment and emotional impact. Adding the SCC into the large amount of information afforded to parents as well as possible adding to exisiting anxieties will need to be analysed.
Timepoint [3] 294548 0
At 6 weeks after birth
Secondary outcome [1] 313335 0
Number of acholic stool is identified by the family or midwife with the SCC.
Timepoint [1] 313335 0
From birth until 6 weeks of life.

Eligibility
Key inclusion criteria
Maori, Pacific Island, European/Pakeha, South Easth Asian families with infants born between March 2015-May 2015.
Minimum age
1 Days
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If pre-term (<36 weeks gestation), any major existing medical conditions eg congenital anomlies or genetic abnormalities.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
10-15 term new-borns and their families from the Wellington and Hutt Valley regions, between 01 March 2015 and 30 May 2015 will be selected using a convenience sampling method. The New Zealand College of Midwives has provided a list of LMC midwives who indicated interest in participating in the study and were willing to enrol families under their care. Ideally, the cohort of 10-15 families will be made up evenly in four groups of families identifying as New Zealand European/Pakeha, Maori, South East Asian and Pacific Islander. The ethnic proportionality acknowledges the fact that Biliary Atresia has increased incidence amongst South East Asians and Pacific Islanders and the need to ensure the SCC would be an acceptable intervention to these families in particular.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Convenience sampling/enrolment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2015
Actual
13/03/2015
Date of last participant enrolment
Anticipated
29/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 6710 0
New Zealand
State/province [1] 6710 0

Funding & Sponsors
Funding source category [1] 290851 0
Government body
Name [1] 290851 0
Ministry of Health
Country [1] 290851 0
New Zealand
Primary sponsor type
Individual
Name
Stanley Ng
Address
Ministry of Health
PO Box 5013
No. 1 The Terrace
Level 1 - CLPR
Wellington 6145
Country
New Zealand
Secondary sponsor category [1] 289541 0
Government body
Name [1] 289541 0
Capital & Coast District Health Board
Address [1] 289541 0
Riddiford Street
Newtown
Wellington 6021
Country [1] 289541 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292467 0
Health & Disability Ethics Committees
Ethics committee address [1] 292467 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO BOX 5013
Wellington 6011
Ethics committee country [1] 292467 0
New Zealand
Date submitted for ethics approval [1] 292467 0
18/02/2015
Approval date [1] 292467 0
27/02/2015
Ethics approval number [1] 292467 0

Summary
Brief summary
To conduct a qualitative study on the implementation of a home-based Stool Colour Chart (SCC) to improve the current opportunistic screening for neonatal cholestasis. Better awareness of acholic stools by families and health professionals is expected to lead to earlier diagnosis and intervention for time-urgent neonatal liver diseases such as Biliary Atresia.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 335 335 0 0
/AnzctrAttachments/368096-Stool Colour Chart Study Proposal v4.pdf

Contacts
Principal investigator
Name 55442 0
Dr Stanley Ng
Address 55442 0
Ministry of Health
PO Box 5013
No. 1 The Terrace
Level 1 - CLPR
Wellington 6145
Country 55442 0
New Zealand
Phone 55442 0
+64 4 816 2046
Fax 55442 0
Email 55442 0
[email protected]
Contact person for public queries
Name 55443 0
Dr Stanley Ng
Address 55443 0
Ministry of Health
PO Box 5013
No. 1 The Terrace
Level 1 - CLPR
Wellington 6145
Country 55443 0
New Zealand
Phone 55443 0
+64 4 816 2046
Fax 55443 0
Email 55443 0
[email protected]
Contact person for scientific queries
Name 55444 0
Dr Stanley Ng
Address 55444 0
Ministry of Health
PO Box 5013
No. 1 The Terrace
Level 1 - CLPR
Wellington 6145
Country 55444 0
New Zealand
Phone 55444 0
+64 4 816 2046
Fax 55444 0
Email 55444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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