Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000529943
Ethics application status
Approved
Date submitted
13/03/2020
Date registered
30/04/2020
Date last updated
19/10/2022
Date data sharing statement initially provided
30/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
MILQ: Mother Infant Lactation Questionnaire
Scientific title
Mother Infant Lactation Questionnaire
Secondary ID [1] 300792 0
None
Universal Trial Number (UTN)
Trial acronym
MILQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant feeding 316658 0
Breast feeding 316659 0
Condition category
Condition code
Diet and Nutrition 314905 314905 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 315018 315018 0 0
Breast feeding

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention.
Infant feeding practices (such as breastfeeding, use of infant formula, introduction of complimentary feeding, variety and type of complimentary foods) will be regularly assessed from as soon after birth (as possible) until the infant is 12 months of age.
Participants will be asked to answer a series of questions about how they feed their infant, either via an online survey or via phone interview with study staff. Participants will be asked to answer these questions at enrollment, and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months and 12 months of age.
Intervention code [1] 317117 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323223 0
The primary objective of MILQ is to understand and document the current feeding practices of South Australian mothers with full-term infants.
The primary outcome is the prevalence of exclusive breastfeeding by mothers of full term infants up to 2 months old. This will be assessed with a study specific questionnaire to be completed by parents via an online survey.
Timepoint [1] 323223 0
Participants complete questions about feeding via an online survey or phone interview with study staff at enrollment and when the infant is 7 weeks of age (window 7 weeks-60 days).
Secondary outcome [1] 381215 0
Prevalence of breastfeeding and proportion of infants ever breastfed.
Participants complete questions about breastfeeding via an online survey or phone interview with study staff. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [1] 381215 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. The survey has been designed specifically for the study and has not been validated.
Secondary outcome [2] 381216 0
Duration of breastfeeding (mean and median) as indicated through questions about breastfeeding via an online survey or phone interview with study staff. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [2] 381216 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.
Secondary outcome [3] 381217 0
Maternal and infant characteristics associated with initiation and continuation of breastfeeding will be measured with a questionnaire that asks about demographic and other characteristics (such as whether the mother was born in Australia, whether the baby was born by caesarean section, did the mother smoke during pregnancy).
This information will be collected through a parent-completed questionnaire that has been designed specifically for the study and has not been validated.
Timepoint [3] 381217 0
baseline/enrollment-shortly after birth.
Secondary outcome [4] 381218 0
Breastfeeding support and resources wanted by mothers will be measured through a questionnaire that asks whether the mother is breastfeeding, and whether they have wanted more support, and what their preferred source of support is (with a list of options to select from-such as lactation consultant, pamphlet, family/friends). The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [4] 381218 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.
Secondary outcome [5] 381219 0
Breastfeeding preferences and intentions of mothers will be assessed by a questionnaire where mothers will be asked how they planned to feed their infant before it was born.The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [5] 381219 0
Participants completed question at enrollment
Secondary outcome [6] 381220 0
Type of first feed will be measured through a questionnaire where parents can select the type of milk (i.e. breastmilk/formula) that the infant was provided for their first feed. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [6] 381220 0
shortly after birth-at enrollment questionnaire.
Secondary outcome [7] 381221 0
Barriers for breastfeeding continuation will be assessed through a questionnaire where women can select from a list things that been difficult or that have discouraged them from breastfeeding. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [7] 381221 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. Participants who have previously indicated they are no longer breastfeeding will not be questioned in subsequent surveys about barriers and enablers.
Secondary outcome [8] 381222 0
Types of foods introduced as first complementary foods will be measured through a questionnaire where parents can select the food group that the infant was provided for their first complimentary feed. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [8] 381222 0
Participants complete questions when the infant is 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.
Secondary outcome [9] 381223 0
Variety of complimentary foods will be measured through a questionnaire where parents can select all food groups that the infant has been provided. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [9] 381223 0
Participants complete questions when the infant is 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.
Secondary outcome [10] 381224 0
Proportion of infants aged 0 to 5 months that were predominantly breastfed will be measured through a repeat questionnaire asking how the infant is fed. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [10] 381224 0
birth-enrolment, 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months and 5 months
Secondary outcome [11] 381225 0
Proportion of infants introduced solid, semi-solid or soft foods by 6 months of age will be measured through a repeat questionnaire. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [11] 381225 0
3 months, 4 months, 5 months and 6 months
Secondary outcome [12] 381680 0
Rationale for breastfeeding preferences and intentions of mothers will be assessed by a questionnaire where mothers will be asked to select from a drop down list why they had planned/preferred to feed their baby as they indicated (i.e. why planned to feed formula/breast milk/both). The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [12] 381680 0
at enrollment
Secondary outcome [13] 381681 0
enablers for breastfeeding continuation will be assessed through a questionnaire where women can select from a list things that have helped them breastfeed. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [13] 381681 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. Participants who have previously indicated they are no longer breastfeeding will not be questioned in subsequent surveys about barriers and enablers.
Secondary outcome [14] 381682 0
reasons for ceasing breastfeeding will be assessed through a questionnaire where women can select from a list things that were difficult or discouraged them from breastfeeding. The questionnaire has been designed specifically for the study and has not been validated.
Timepoint [14] 381682 0
Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. Participants who have previously indicated they are no longer breastfeeding will not be questioned in subsequent surveys about barriers and enablers.

Eligibility
Key inclusion criteria
• Term-born (37+0 to 41+6 weeks)
• Singleton birth
• Appropriate birth weight for gestational age (weight >5th and <95th percentile: boys 2,604-4,215 grams, girls 2,532-4,041 grams)
• Caregiver or legally authorised representative is over the age of 16 years
• Caregiver or legally authorised representative is able to provide informed consent
Minimum age
0 Days
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
preterm birth
Multiple pregnancy


Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The data collected will be a mixture of categorical, continuous, dichotomous and free text responses. A detailed statistical analysis plan for each individual research objective will be carried out in consultation with an experienced biostatistician, and appropriate controls/confounders included in the statistical model.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
27/02/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
11/07/2022
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
1000
Accrual to date
Final
1281
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305249 0
Commercial sector/Industry
Name [1] 305249 0
FONTERRA CO-OPERATIVE GROUP LIMITED
Country [1] 305249 0
New Zealand
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
72 King William Road
North Adelaide, South Australia
Australia, 5006
Country
Australia
Secondary sponsor category [1] 305609 0
None
Name [1] 305609 0
Address [1] 305609 0
Country [1] 305609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305592 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC)
Ethics committee address [1] 305592 0
Ethics committee country [1] 305592 0
Australia
Date submitted for ethics approval [1] 305592 0
29/08/2019
Approval date [1] 305592 0
22/11/2019
Ethics approval number [1] 305592 0

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

Contacts
Principal investigator
Name 100890 0
Prof Maria Makrides
Address 100890 0
Theme Leader SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006
Country 100890 0
Australia
Phone 100890 0
+61 8 8128 4416
Fax 100890 0
Email 100890 0
[email protected]
Contact person for public queries
Name 100891 0
Jacqueline Gould
Address 100891 0
SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006
Country 100891 0
Australia
Phone 100891 0
+61 8 8128 4423
Fax 100891 0
Email 100891 0
[email protected]
Contact person for scientific queries
Name 100892 0
Jacqueline Gould
Address 100892 0
SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006
Country 100892 0
Australia
Phone 100892 0
+61 8 8128 4423
Fax 100892 0
Email 100892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de-identified data may be shared, with the written approval of the study steering committee and the WCHN HREC. Data will not be made publicly available in a data repository.
When will data be available (start and end dates)?
Requests for data sharing may be made after 2023, with no applicable end date.
Available to whom?
Data may be shared with researchers, government or health professionals who provide a methodologically sound proposal that is approved by the study steering committee and the WCHN HREC.
Available for what types of analyses?
Analyses to achieve the aims of the proposal that is approved by the study steering committee and the WCHN HREC.
How or where can data be obtained?
Data can be requested from the study steering committee (via. Dr Jacqueline Gould through email: [email protected]).


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
SourceTitleYear of PublicationDOI
Dimensions AINew Methodologies for Conducting Maternal, Infant, and Child Nutrition Research in the Era of COVID-192021https://doi.org/10.3390/nu13030941
N.B. These documents automatically identified may not have been verified by the study sponsor.