Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000180415
Ethics application status
Approved
Date submitted
10/01/2025
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal perception vs actual breast milk supply: is there a difference?
Scientific title
Describing and comparing breast milk volumes produced by a diverse sample of lactating mother's of 3-month-old infants with differing perceptions of breast milk supply using the gold standard dose-to-mother deuterium oxide (D2O) technique.
Secondary ID [1] 312480 0
None
Universal Trial Number (UTN)
Trial acronym
MABBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived insufficient milk supply (PIMS) 335972 0
Condition category
Condition code
Reproductive Health and Childbirth 332562 332562 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
Saliva samples will be collected from mothers and infants at the first appointment, before administration of 30g of the stable isotope (deuterium oxide) (as a drink) to the mother by a trained researcher. Saliva samples will be taken from the mother and baby at the second visit (2 days post dose), third visit (7 days post dose) and fourth visit (14 days post dose) to measure the disappearance of deuterium from the mother and appearance in the infant (i.e. via the mothers breast milk). We will also ask mothers to collect an at home saliva sample on themselves (not the infant) 3-5 hours after stable isotope administration for body composition calculations. Infant weight and length will be taken at the first, fourth and fifth visit. Maternal weight and height will be taken at the first appointment. Data will be collected on demographics, maternal perception of breast milk supply, breastfeeding self-efficacy, infant sleep, as well as maternal stress and sleep, maternal health history (including eating patterns), and family factors (e.g., childcare attendance). The mother will be asked to pump a full breast milk expression and provide us with a 12ml sample as soon as possible after the fourth visit, for breast milk nutrient composition analysis. Visits one to four will be conducted by a trained researcher. A breastfeeding observation and oral assessment will be conducted at the fifth visit (approximately two weeks after the fourth visit) by an International Board Certified Lactation Consultant (IBCLC) to: a) observe for correct latch and positioning, as well as active and nonnutritive feeding, b) perform an oral assessment on the baby to identify any oral anomalies that could be causing transfer of breast milk issues, and c) perform a test-weight to get a one off estimate of milk transfer. Any latch/transfer issues observed during the feeding or discovered by the questionnaire will be noted by the Lactation Consultant. The mother will be asked questions on usual feeding and latching. With the mothers' permission, any appropriate referrals will be made (e.g., GP, specialist) and/or support provided by the Lactation Consultant for any concerns that may have arisen during the assessment. A final short (three question) survey will be sent to participants at the end of the study to assess how they felt after discussing breastfeeding with the Lactation Consultant. In total, participants will be asked to attend five visits over 4 weeks.
Intervention code [1] 330103 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340072 0
Breast milk intake of infants aged 3 months
Timepoint [1] 340072 0
Visit one (between an infant age of 3-3.99 months) Visit two (approximately two days after visit one) Visit three (approximately seven days after visit one) Visit four (approximately 14 days after visit one)
Primary outcome [2] 340073 0
Mothers perception of breast milk supply at 3 months postpartum
Timepoint [2] 340073 0
Visit one (between an infant age of 3-3.99 months) Visit two (approximately two days after visit one) Visit three (approximately seven days after visit one) Visit four (approximately 14 days after visit one) Visit five (approximately 4 weeks after visit one)
Secondary outcome [1] 442559 0
Infant growth from birth to 5 months
Timepoint [1] 442559 0
Visit one (between an infant age of 3-3.99 months) Visit four (approximately 14 days after visit one) Visit five (approximately four weeks after visit one)
Secondary outcome [2] 442560 0
Breast milk nutrient composition at 3 months postpartum
Timepoint [2] 442560 0
After visit four (approximately 14 days after visit one)
Secondary outcome [3] 442562 0
Prevalence of expressing breast milk at 3 months postpartum
Timepoint [3] 442562 0
Visit one (between an infant age of 3-3.99 months)
Secondary outcome [4] 442563 0
Infant sleep
Timepoint [4] 442563 0
Visit one (between an infant age of 3-3.99 months)
Secondary outcome [5] 444036 0
Single test-weight of breast milk transfer
Timepoint [5] 444036 0
Visit five (approximately 4 weeks after visit one)
Secondary outcome [6] 444037 0
Maternal body composition
Timepoint [6] 444037 0
Visit one (between an infant age of 3-3.99 months) Additional saliva sample collection (3-5 hours after visit one) Visit two (approximately two days after visit one) Visit three (approximately seven days after visit one) Visit four (approximately 14 days after visit one)

Eligibility
Key inclusion criteria
Lactating mothers who:
- Are 16 years of age or older.
- Live in Dunedin, New Zealand (within a 30 km radius).
- Have an infant aged 3.0-3.99 months, at the time of participation.
- Are fully breastfeeding (breast milk only) for 2 weeks prior to recruitment.
- Are intending to continue fully breastfeeding for the remainder of study participation.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Mother is not able to communicate in English.
- Mother is tandem breastfeeding (simultaneously breastfeeding another child) or breastfeeding multiples (twins or higher order multiples).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
We anticipate a dropout rate, including incomplete data, of 20% based on recruitment and completion data from recent studies. We aim to recruit 150 mother baby dyads. Therefore, with 120 mother baby dyads (excluding dropout), mean breast milk volume can be estimated to a 95% confidence level of +/-0.18 SD. If the distribution of intakes is similar to other data, this may be around ±27 mL/d (i.e. 3% of an estimated intake of 787 mL/d at 3 months). 120 participants will provide a robust sample size to estimate the correlation between breast milk volume and PIMS as well as estimating differences between groups.

We will describe breast milk intakes of infants at 3 months of age. Regression models will be used to assess how maternal perception of breast milk supply is associated with actual breast milk volumes produced by lactating mothers at 3 months postpartum. Pre-determined potential predictors (e.g., maternal body composition, maternal BMI, infant BMI, perception of milk supply, breastfeeding self-efficacy) of actual breast milk supply will be described using appropriate regression modelling. Perception of milk supply will be collected as a continuous scale and dichotomised to create a variable for comparing low (insufficient) perceived milk supply and high (oversupply) perceived milk supply.

Infant weight and length data will be used to calculate Body Mass Index (BMI) and to determine BMI-for-age z-score using sex specific reference data from the World Health Organization (WHO) Child Growth Standards. BMI and weight velocity between birth and 5 months will be calculated. We will conduct an initial investigation into whether breast milk volumes produced and infant growth overtime (birth to 5 months) can be used to asses breast milk inadequacy (actual low milk supply), using mixed effects models.

Statistical analyses will be conducted under the guidance of a biostatistician and using Stata version 18 (StataCorp, TX) software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 26773 0
New Zealand
State/province [1] 26773 0
Otago

Funding & Sponsors
Funding source category [1] 316898 0
Government body
Name [1] 316898 0
Health Research Council of New Zealand
Country [1] 316898 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320325 0
None
Name [1] 320325 0
Address [1] 320325 0
Country [1] 320325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315659 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 315659 0
Ethics committee country [1] 315659 0
New Zealand
Date submitted for ethics approval [1] 315659 0
03/09/2024
Approval date [1] 315659 0
06/10/2024
Ethics approval number [1] 315659 0
H24/0225

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

Contacts
Principal investigator
Name 135406 0
Dr Lisa Daniels
Address 135406 0
University of Otago PO Box 56 Dunedin 9054 New Zealand
Country 135406 0
New Zealand
Phone 135406 0
+64 3 556 5071
Fax 135406 0
Email 135406 0
[email protected]
Contact person for public queries
Name 135407 0
Lisa Daniels
Address 135407 0
University of Otago PO Box 56 Dunedin 9054 New Zealand
Country 135407 0
New Zealand
Phone 135407 0
+64 3 556 5071
Fax 135407 0
Email 135407 0
[email protected]
Contact person for scientific queries
Name 135408 0
Lisa Daniels
Address 135408 0
University of Otago PO Box 56 Dunedin 9054 New Zealand
Country 135408 0
New Zealand
Phone 135408 0
+64 3 556 5071
Fax 135408 0
Email 135408 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To ensure confidentiality for participants.



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.