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Trial registered on ANZCTR


Registration number
ACTRN12621000503820
Ethics application status
Approved
Date submitted
31/03/2021
Date registered
29/04/2021
Date last updated
17/03/2024
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying predictors of breast milk supply following preterm birth- the PROMO study
Scientific title
Predictors Of Milk Output following preterm birth (PROMO)- a prospective cohort study
Secondary ID [1] 303150 0
None
Universal Trial Number (UTN)
U1111-1263-7614
Trial acronym
PROMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lactation insufficiency 320263 0
Preterm birth 321751 0
Condition category
Condition code
Reproductive Health and Childbirth 318194 318194 0 0
Breast feeding
Reproductive Health and Childbirth 319491 319491 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
Women who have given birth to a preterm infant at less than 34 weeks' completed gestation, and who intend to breastfeed, will be recruited between 0 and 168 hours following birth. Participants will be assessed at regular intervals for up to 36 months infant corrected age. All participants will undertake regular study assessments including at baseline (day 1-7), 7, 14, 21 post-birth, at infant discharge to home or term corrected (whichever comes first), one-month, three-months and six-months infant corrected age. A medical record audit will be conducted at 24-36 months corrected age. Study assessments at baseline, day 7, 14, 21 post-birth, infant discharge/term corrected age and at three-months infant corrected age will be conducted face-to-face, whereas one-month and six-month study visits will be conducted by telephone.

As part of the study, women will complete a breast milk diary until 21 days postpartum. Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices, anticipated to take 30-60 minutes at each session. Women will provide breast milk, blood, urine, stool and buccal cell swab samples, collected and processed by research staff.
Intervention code [1] 319457 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326175 0
Breast milk volume over 24 hours. Identified through expressed volume over a 24-hour period using a breast milk diary completed by the mother.
Timepoint [1] 326175 0
Day 21 postpartum
Secondary outcome [1] 390387 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 [1] 390387 0
Day 21 postpartum, at infant discharge from hospital or infant term corrected age (if this occurs before discharge) and at 6 months infant corrected age.
Secondary outcome [2] 393537 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-feeding it to the infant), collected through maternal self-report and infant case note review during hospitalisation.
Timepoint [2] 393537 0
Day 21 postpartum, at infant discharge from hospital or infant term corrected age (if this occurs before discharge) and at 6 months infant corrected age.
Secondary outcome [3] 393538 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-feeding it to the infant), extracted from infant feeding records up until infant discharge and from maternal self-report thereafter.
Timepoint [3] 393538 0
Until 6 months infant corrected age.
Secondary outcome [4] 393539 0
Average daily breast milk volume, using a breast milk diary completed by the mother.
Timepoint [4] 393539 0
From study enrolment until day 21 postpartum.
Secondary outcome [5] 393542 0
Breast health will be assessed to assist in identifying mastitis using a questionnaire that screens for local and systemic symptoms. The Breast Health Questionnaire was designed specifically for this study, based on the work of Dr Catherine Fetherston.
FETHERSTON, C. 2003. Relationships between clinical descriptors and changes in the physiology of the lactating breast before, during and after non-inflammatory and inflammatory breast disorders. Thesis (Ph.D.)--University of Western Australia, 2004.
Timepoint [5] 393542 0
Day 7, Day 14 and Day 21 postpartum and at infant discharge from hospital or infant term corrected age (if this occurs before discharge).
Secondary outcome [6] 393543 0
Maternal anxiety assessed using State-Trait Anxiety Inventory (STAI)
Timepoint [6] 393543 0
Day 7 and day 21 postpartum, infant discharge from hospital or infant term corrected age (if this occurs before discharge) and at 3 and 6 months infant corrected age.
Secondary outcome [7] 393549 0
Maternal depression assessed using Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [7] 393549 0
Day 7 and day 21 postpartum, infant discharge from hospital or infant term corrected age (if this occurs before discharge) and at 3 and 6 months infant corrected age
Secondary outcome [8] 393571 0
Maternal quality of life assessed using the SF-36
Timepoint [8] 393571 0
Three months infant corrected age
Secondary outcome [9] 393572 0
Maternal postnatal attachment - assessed using Maternal Postnatal Attachment Scale
Timepoint [9] 393572 0
Infant discharge from hospital or infant term corrected age (if this occurs before infant discharge) and 3 months infant corrected age.
Secondary outcome [10] 393578 0
Infant neurodevelopment as assessed by the Bayley Scales of Infant and Toddler Development
Timepoint [10] 393578 0
At a single timepoint between 2-3 years infant corrected age

Eligibility
Key inclusion criteria
- Infant born <34 weeks’ gestation (i.e. up to 33+6)
- Intention to provide breast milk
- Between 0 to 168 hours (7 days) following birth
- Willing and able to comply with all study requirements
- Adequate English language skills
- Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to breastfeeding (i.e. HIV)
- Higher order pregnancies (triplet or more)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 200 women provides 80% power to detect a difference of 100 mL/day in mean daily breast milk volume according to a factor that occurs in as few as 25% of participants. This is based on a type I error rate of 5% and an estimated standard deviation of 200 mL.

The primary outcome of daily breast milk volume on day 21 will be compared 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. 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 potential confounders. 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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2021
Actual
24/06/2021
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
200
Accrual to date
69
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18392 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 18393 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 32482 0
5006 - North Adelaide
Recruitment postcode(s) [2] 32483 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 307554 0
Government body
Name [1] 307554 0
National Health and Medical Research Council
Country [1] 307554 0
Australia
Funding source category [2] 307622 0
Charities/Societies/Foundations
Name [2] 307622 0
The Hospital Research Foundation
Country [2] 307622 0
Australia
Funding source category [3] 307624 0
Charities/Societies/Foundations
Name [3] 307624 0
Rebecca L Cooper Medical Research Foundation
Country [3] 307624 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
North Terrace
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 308243 0
None
Name [1] 308243 0
Address [1] 308243 0
Country [1] 308243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307618 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 307618 0
Ethics committee country [1] 307618 0
Australia
Date submitted for ethics approval [1] 307618 0
10/06/2020
Approval date [1] 307618 0
05/08/2020
Ethics approval number [1] 307618 0
HREC/20/WCHN/68

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

Contacts
Principal investigator
Name 107882 0
A/Prof Luke Grzeskowiak
Address 107882 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107882 0
Australia
Phone 107882 0
+61 423 554 614
Fax 107882 0
Email 107882 0
luke.grzeskowiak@flinders.edu.au
Contact person for public queries
Name 107883 0
Luke Grzeskowiak
Address 107883 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107883 0
Australia
Phone 107883 0
+61 423 554 614
Fax 107883 0
Email 107883 0
luke.grzeskowiak@flinders.edu.au
Contact person for scientific queries
Name 107884 0
Luke Grzeskowiak
Address 107884 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107884 0
Australia
Phone 107884 0
+61 423 554 614
Fax 107884 0
Email 107884 0
luke.grzeskowiak@flinders.edu.au

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, including 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 (luke.grzeskowiak@flinders.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11231Study protocol  luke.grzeskowiak@flinders.edu.au
11232Informed consent form  luke.grzeskowiak@flinders.edu.au
11233Ethical approval  luke.grzeskowiak@flinders.edu.au



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.