Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000933459p
Ethics application status
Submitted, not yet approved
Date submitted
30/06/2025
Date registered
28/08/2025
Date last updated
28/08/2025
Date data sharing statement initially provided
28/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feeding practices in infants and young children with Cystic Fibrosis: An Australian survey of caregivers.
Scientific title
Feeding practices in infants and young children with Cystic Fibrosis: An Australian survey of caregivers.
Secondary ID [1] 314777 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 338008 0
infant feeding 338279 0
Condition category
Condition code
Diet and Nutrition 334323 334323 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 334583 334583 0 0
Breast feeding
Human Genetics and Inherited Disorders 334651 334651 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this cross-sectional national survey is to explore the early life feeding practices of infants and children with cystic fibrosis in Australia, with a focus on exclusive and partial breastfeeding rates throughout infancy, determinants to breastfeeding cessation, infant formula introduction and the timing and practices associated with transition to solid foods. The project duration is 6 months. Mother/primary caregiver will be asked to complete the survey. The survey will only be completed once. Survey duration is ~ 10 mins.
Intervention code [1] 331378 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341983 0
Breastfeeding rates throughout the first 12 months of life in infants and children with Cystic Fibrosis (CF) 0-2 years of age.
Timepoint [1] 341983 0
At the time of survey completion.
Secondary outcome [1] 449238 0
Utilisation of lactation consultants by mothers of breastfed infants with CF.
Timepoint [1] 449238 0
At the time of survey completion.
Secondary outcome [2] 449239 0
Mother/caregiver-reported reasons for breastfeeding cessation.
Timepoint [2] 449239 0
At the time of survey completion.
Secondary outcome [3] 449240 0
Infant formula practices throughout the first 12 months of life in infants and children with Cystic Fibrosis (CF) 0-2 years of age.
Timepoint [3] 449240 0
At the time of survey completion.
Secondary outcome [4] 449241 0
Solid food transition practices throughout the first 12 months of life in infants and children with Cystic Fibrosis (CF) 0-2 years of age.
Timepoint [4] 449241 0
At the time of survey completion.

Eligibility
Key inclusion criteria
Mother/caregiver of cwCF <2 years of age (i.e. 0-1.9 years of age) living in Australia during the designated 3 month study period and receiving their CF care at one of the included sites. Mother/caregiver must have sufficient English language to complete the survey. Alternatively, if an interpreter has been booked for the duration of the CF outpatient clinic as part of routine clinical care, then the interpreter could facilitate consent and completion of the survey.


Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Mother/caregiver has insufficient English to provide consent and complete the survey and no interpreter in available/booked for their CF clinic time. Participants deemed not to have sufficient capacity by site PI or AI (by means of recall after explanation of the study and provision of the PIS) to consent will not proceed with participation, on the clinical judgement of the site PI or AI.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To determine an accurate statistical prevalence of breastfeeding in infants and cwCF living in Australia, with a confidence interval of 0.05, a standard error of 0.03 at the 95% confidence interval, a sample size of 95 participants is required. The project duration of 6 months is sufficient to gain statistical significance. Raw data will be exported from Qualtrics Plus. Appropriate descriptive statistics (depending on distribution of data and continuous vs. categorical variables) will be provided following cleaning and coding. T-tests, Chi-squared as well as univariate and multivariable and/or logistic regression models will be used to identify associations between infant and maternal characteristics and exclusivity and duration of breastfeeding; precise statistical methods will depend on number of responses. A p value of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 319331 0
Government body
Name [1] 319331 0
Monash Health
Country [1] 319331 0
Australia
Primary sponsor type
Government body
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 322021 0
University
Name [1] 322021 0
Monash University
Address [1] 322021 0
Country [1] 322021 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317914 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 317914 0
Ethics committee country [1] 317914 0
Australia
Date submitted for ethics approval [1] 317914 0
23/03/2025
Approval date [1] 317914 0
Ethics approval number [1] 317914 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142534 0
Ms Caitlin Miles
Address 142534 0
Monash Children's Hospital 246 Clayton Road, Clayton VIC 3168
Country 142534 0
Australia
Phone 142534 0
+61 434671696
Fax 142534 0
Email 142534 0
[email protected]
Contact person for public queries
Name 142535 0
Caitlin Miles
Address 142535 0
Monash Children's Hospital 246 Clayton Road, Clayton VIC 3168
Country 142535 0
Australia
Phone 142535 0
+61 434671696
Fax 142535 0
Email 142535 0
[email protected]
Contact person for scientific queries
Name 142536 0
Caitlin Miles
Address 142536 0
Monash Children's Hospital 246 Clayton Road, Clayton VIC 3168
Country 142536 0
Australia
Phone 142536 0
+61 434671696
Fax 142536 0
Email 142536 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Results will be collated and shared once analysed collectively. Survey is anonymous so no individual participant data will be available for sharing.



What supporting documents are/will be available?

No Supporting Document Provided


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.