Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000968774
Ethics application status
Approved
Date submitted
6/07/2022
Date registered
8/07/2022
Date last updated
17/03/2024
Date data sharing statement initially provided
8/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The BLOOM Study - can brewer's yeast or beta-glucan increase breast milk supply following preterm birth?
Scientific title
The BLOOM Study - can Brewer’s yeast or beta-gLucan increase mOther’s Own Milk supply following preterm birth?
Secondary ID [1] 307265 0
None
Universal Trial Number (UTN)
U1111-1278-8827
Trial acronym
BLOOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lactation insufficiency 326519 0
Preterm birth 326520 0
Condition category
Condition code
Reproductive Health and Childbirth 323783 323783 0 0
Breast feeding
Reproductive Health and Childbirth 323784 323784 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Brewer's Yeast, three 280 mg capsules administered orally twice a day (morning and evening), for a total daily dose of 1680 mg/day, intervention duration of seven days.

Arm 2 - Beta-glucan, one 250 mg capsule administered orally once per day (morning), administered with two placebo capsules in the morning and three placebo capsules in the evening, intervention duration of seven days.
Intervention code [1] 323702 0
Treatment: Drugs
Comparator / control treatment
Placebo - capsules containing microcrystalline cellulose, three capsules administered in the morning and three in the evening, orally, for seven days.
Control group
Placebo

Outcomes
Primary outcome [1] 331555 0
Daily expressed breast milk volume. Identified from expressed volume recorded over a 24-hour period using a breast milk diary completed by mothers.
Timepoint [1] 331555 0
Day 7 of the intervention
Secondary outcome [1] 410248 0
Maternal adverse events will be assessed using a study-specific questionnaire with reference to known/possible adverse events including diarrhoea, nausea, vomiting, abdominal pain, cramping and rash.
Timepoint [1] 410248 0
From first study dose up to day 7 of intervention.
Secondary outcome [2] 410249 0
Use and volume of supplementation to mother's own breast milk, such as formula or donor breast milk, extracted from infant medical records
Timepoint [2] 410249 0
Day 7 of intervention and at infant discharge from hospital or infant term corrected age (if this occurs before discharge)
Secondary outcome [3] 410250 0
Proportion breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle or nasogastric tube feeding it to the infant), collected through maternal self-report and case note review.
Timepoint [3] 410250 0
At infant discharge from hospital or infant term corrected age (if this occurs before discharge)
Secondary outcome [4] 410251 0
Duration of breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle or nasogastric tube feeding it to the infant), collected through maternal self-report and case note review.
Timepoint [4] 410251 0
Until infant discharge from hospital or infant term corrected age (if this occurs before discharge)
Secondary outcome [5] 410252 0
Mean daily breast milk volume using a breast milk diary completed by the mother
Timepoint [5] 410252 0
From day 0 of intervention to postnatal day 21
Secondary outcome [6] 410253 0
Total breast milk volume assessed using a breast milk diary completed by the mother
Timepoint [6] 410253 0
Day 0 of intervention to postnatal day 21
Secondary outcome [7] 410254 0
Maternal serum prolactin concentration
Timepoint [7] 410254 0
Day 7 of intervention
Secondary outcome [8] 410255 0
Breast milk composition assessed by measuring protein, fat, and carbohydrate concentration
Timepoint [8] 410255 0
Day 7 of intervention
Secondary outcome [9] 411718 0
Treatment adherence as measured by participant diary
Timepoint [9] 411718 0
Day 7 of intervention

Eligibility
Key inclusion criteria
- Infant born <34 weeks’ gestation (i.e. up to 33+6)
- Intention to provide breast milk
- Between 0 to 72 hours of birth
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Adequate English language skills
- Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Contraindication to breastfeeding
- Higher order pregnancies (triplet or more)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will follow a computer generated randomisation schedule using randomly permuted blocks. Randomisation stratified by study centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample of 99 women (33 per arm) yields 90% power, 0.025 alpha to show a difference in the mean daily breast milk volume of 150 mL/day (200 mL/day standard deviation) between each of the intervention arms and control, allowing for 10% loss to follow-up. This includes adjustment for a 0.6 correlation between breast milk volume at study entry and breast milk volume on day 7.

The primary analysis will be performed according to the treatment group to which participants were randomised (intention-to-treat principle). A secondary per-protocol analysis will also be performed for each of the primary and secondary outcomes.
The primary outcome of daily breast milk volume on day 7 will be compared between treatment groups using a linear regression. The results will be expressed as a difference in means with a 95% confidence interval and two-sided p-value. Adjustment will be made for baseline breast milk volume and the randomization strata (study centre). A p-value of less than 0.05 will be considered to indicate statistical significance. Analysis of secondary outcomes will use log-binomial regression models for binary outcomes and linear regression models for continuous outcomes with adjustment for stratification variables and other pre-specified prognostic baseline variables. Results will be presented as relative risks and differences in means respectively, along with 95% confidence intervals. Missing data will be addressed using multiple imputation. Sensitivity analyses will also be performed using the original unimputed data.

Planned sub-group analyses of the primary and secondary breastfeeding outcomes include:
(i) Plurality (Singleton vs. twins)
(ii) Parity (Primiparous vs. multiparous)
(iii) Infant gestation at birth (23+0–29+6 vs. 30+0–31+6 vs 32+0-33+6 weeks’ gestation)
(iv) Maternal body mass index (Underweight/Normal weight vs. Overweight/Obese)
Effect modification by each of these factors will be assessed separately by including interaction effects with treatment group in the statistical models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
19/08/2022
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
99
Accrual to date
97
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22477 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 22478 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 25217 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 37711 0
5006 - North Adelaide
Recruitment postcode(s) [2] 37712 0
5042 - Bedford Park
Recruitment postcode(s) [3] 40888 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 311561 0
University
Name [1] 311561 0
Flinders University
Country [1] 311561 0
Australia
Funding source category [2] 311566 0
Commercial sector/Industry
Name [2] 311566 0
Leiber GmbH
Country [2] 311566 0
Germany
Funding source category [3] 311649 0
Charities/Societies/Foundations
Name [3] 311649 0
Channel 7 Children's Research Foundation
Country [3] 311649 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
North Terrace
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 312978 0
None
Name [1] 312978 0
Address [1] 312978 0
Country [1] 312978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311010 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 311010 0
Ethics committee country [1] 311010 0
Australia
Date submitted for ethics approval [1] 311010 0
22/01/2022
Approval date [1] 311010 0
31/03/2022
Ethics approval number [1] 311010 0
HREC/22/WCHN/00001

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

Contacts
Principal investigator
Name 119686 0
A/Prof Luke Grzeskowiak
Address 119686 0
College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia
Country 119686 0
Australia
Phone 119686 0
+61 423 554 614
Fax 119686 0
Email 119686 0
[email protected]
Contact person for public queries
Name 119687 0
Luke Grzeskowiak
Address 119687 0
College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia
Country 119687 0
Australia
Phone 119687 0
+61 423 554 614
Fax 119687 0
Email 119687 0
[email protected]
Contact person for scientific queries
Name 119688 0
Luke Grzeskowiak
Address 119688 0
College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia
Country 119688 0
Australia
Phone 119688 0
+61 423 554 614
Fax 119688 0
Email 119688 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?
Baseline Characteristics: including demographics, age and study-specific measures for all participants, after de-identification.
Outcome data: all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months following main results publication; no end date determined
Available to whom?
To researchers who provide a methodologically sound proposal, and on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16267Study protocol  [email protected]
16268Informed consent form  [email protected]
16269Ethical approval  [email protected]



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.