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Trial registered on ANZCTR


Registration number
ACTRN12617000769381
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
25/05/2017
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Date results information initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Early establishment of breast milk supply in mothers of preterm infants; comparing hand expressing and massage within the first hour of birth to expressing in the first 6 hours.
Scientific title
Feasibility of study methods of breast massage and hand expressing of breast milk within the first hour of birth to standard care (expressing only in the first 6 hours) for mothers of preterm infants between 28 and 34 weeks’ gestation: a pilot randomised controlled trial
Secondary ID [1] 291956 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PREM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 303324 0
Mastitis 303325 0
Engorgement 303326 0
Breast milk supply 303327 0
Premature infants 303328 0
Condition category
Condition code
Reproductive Health and Childbirth 302764 302764 0 0
Breast feeding
Reproductive Health and Childbirth 302823 302823 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is hand expressing and massage within one hour of birth. The education session will take approximately 30mins including education and demonstration and handing out the education materials.
Massage will be taught by a lactation consultant at recruitment and undertaken by the mother within the first hour following preterm birth with the supervision of a midwife.
Massage duration is 1-3 minutes prior to hand expressing. Massage steps include lifting the breast up and holding, while holding with one hand use the pads of the middle three fingers and rub in a circular motion around the entire breast so it shakes. Using same motion rub the pectoral muscle (at the top of the chest) to loosen and either side of your sternum (breast bone). Instruction for the massage and hand expression will be provided on a palm sized card for reference during massage
Hand expression will be demonstrated at recruitment and the participant will demonstrate this back to the lactation consultant. The partner if available will also be educated to assist the participant. Hand expression education is as follows; Position your thumb and first two fingers about 2.5–4 cm behind the nipple. Place your thumb pad above the nipple and the finger pads below the nipple forming the letter "C". Push straight back into the chest wall. Press thumb and fingers together gently behind the nipple and then release. Repeat step two and three to establish milk flow. Rotate your thumb and finger position to milk the other ducts. Any handling of your breast should be gentle and non-painful. If discomfort occurs, move your fingers further behind the areola which should increase comfort as well as milk flow. Information handout will be given to the mothers as a reference guide.
Participants will be asked to document the date and time of their first expression on an expressing log provided at recruitment, this will include an area for the participant to tick that massage was undertaken.
Participants can use these techniques following the initial expression within the first hour and will document on their expressing log if they used massage or hand expression to express.
Intervention code [1] 298098 0
Prevention
Comparator / control treatment
Control - Standard care, expressing by hand or pump within 6 hours of birth of a premature infant between 28 and 34 weeks gestation.
Control group
Active

Outcomes
Primary outcome [1] 302146 0
Number of preterm births (28-34 weeks) each week will be documented during the 6 months trial period by reviewing the admissions to the neonatal nursery and confirming with the patient bed lists for the hospital.
Timepoint [1] 302146 0
6 months
Primary outcome [2] 302147 0
Number of women recruited
Timepoint [2] 302147 0
6 months
Primary outcome [3] 302148 0
Proportion of potentially eligible women not recruited and reasons. This will be measured by auditing the consent process and and reason for not consenting as well as reviewing admissions to the neonatal nursery and patient bed lists.
Timepoint [3] 302148 0
6 months
Secondary outcome [1] 334966 0
Total volume of milk expressed from birth to end of day 7. All mothers will be educated on measuring with a syringe and provided with 1ml, 3ml, 5ml and 10ml syringes to document amount of breast milk following each expression session. When milk is flowing into a bottle mothers will be asked to extract the milk into a syringe to accurately measure the amount and document. Large quantities of milk will be transferred back into the bottle for storage. This will be reported on the expressing log given to mothers at time of consent.
Timepoint [1] 334966 0
7 days from birth of premature baby.
Secondary outcome [2] 334967 0
Time to establish milk supply, this will be measured by the mothers symptoms and a time frame given. Data on signs of lactogenesis stage II or ‘milk coming in’ will be collected from the expressing log as charted by the participant reporting the following signs: Maternal perception of the onset of lactation, swelling, fullness, engorgement and leaking of the breast as reported by the participant each day to determine time of milk coming in. Milk volume will be correlated with the mothers’ signs of milk coming in and time will be recorded in 12-hour increments as either occurring 0800–2000h or 2000–0800h. This is a traditional method of determining timing of milk coming in and has been shown to correlate with actual timing of this stage.
Timepoint [2] 334967 0
Data collected for milk coming in will be collected over the first 7 days from birth or up to day 14 post birth if milk has not come in by this time point.
Secondary outcome [3] 334968 0
Experience of engorgement in first 2 weeks. Participants will be asked if they experienced engorgement in the first 2 weeks including signs of redness, swelling and pain, a yes or no answer will be recorded.
Timepoint [3] 334968 0
Up to day 14
Secondary outcome [4] 335168 0
Experience of mastitis in the first 3 months. Participants will be asked if they experienced mastitis symptoms in the first 3 months, including signs of redness, swelling, pain or temperatures above 38.5, a yes or no answer will be recorded.
Timepoint [4] 335168 0
Measured from birth to 3 months. Mothers may experience mastitis at any time point in their experience of expressing and breastfeeding. Study timeline is first 3 months from birth.
Secondary outcome [5] 337401 0
Were participants prescribed antibiotics for mastitis in the first 3 months. Mothers will be asked whether they were prescribed and took antibiotics in the first 3 months post-partum.
Timepoint [5] 337401 0
Measured from birth to 3 months.

Eligibility
Key inclusion criteria
1. 16 years of age or older
2. Preterm birth 28 to 35 completed weeks gestation
3. Maternal intention to breast-feed
4. Able to provide informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Less than 16 years of age
2. No intention to breastfeed
3. History of breast reduction or augmentation
4. Mother admitted to intensive care unit post birth

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequentially numbered envelopes prepared by a research assistant
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To estimate the sample size for this study two areas were looked at, firstly, time frame to complete the study and secondly, the amount of preterm births at the research facility. Approximately 500 preterm births under 34 weeks gestation occur at the study setting per year. An estimate of 30 mothers of preterm infants over 6 months was considered feasibly for this pilot RCT.

Simple descriptive stats will describe the primary outcomes of the pilot study. For secondary clinical outcomes, means and standard deviations will be used for normally distributed data with medians and interquartile ranges for non-parametric. Categorical variables will be presented as number/percent.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2018
Actual
15/02/2018
Date of last participant enrolment
Anticipated
15/09/2018
Actual
19/03/2019
Date of last data collection
Anticipated
15/12/2018
Actual
27/06/2019
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8027 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 16013 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 296471 0
Charities/Societies/Foundations
Name [1] 296471 0
Mater Foundation - Betty McGrath Fellowship Scheme
Country [1] 296471 0
Australia
Primary sponsor type
Individual
Name
Sue Kildea
Address
Mater Health Services
Midwifery Research Unit
Raymond Terrace, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 295426 0
Individual
Name [1] 295426 0
Nigel Lee
Address [1] 295426 0
Mater Health Services
Midwifery Research Unit
Raymond Terrace, South Brisbane QLD 4101
Country [1] 295426 0
Australia
Secondary sponsor category [2] 295448 0
Individual
Name [2] 295448 0
Kathryn Kynoch
Address [2] 295448 0
Mater Health Services
Evidence in Practice Unit
Raymond Terrace, South Brisbane QLD 410
Country [2] 295448 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297692 0
Mater Research - Human Research Ethics and Governance
Ethics committee address [1] 297692 0
Raymond Terrace, South Brisbane QLD 4101
Ethics committee country [1] 297692 0
Australia
Date submitted for ethics approval [1] 297692 0
07/08/2017
Approval date [1] 297692 0
05/10/2017
Ethics approval number [1] 297692 0

Summary
Brief summary
To reduce breastfeeding complications in mothers of preterm infants by initiating expressing and massage within the first hour of birth as compared to one to six hours of birth or later. A pilot RCT will be used to inform the study methods to design a larger RCT.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74846 0
Mrs Loretta Anderson
Address 74846 0
Mater Health Services
Evidence in Practice Unit
Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country 74846 0
Australia
Phone 74846 0
+61 7 3163 5368
Fax 74846 0
Email 74846 0
loretta.anderson@mater.org.au
Contact person for public queries
Name 74847 0
Mrs Loretta Anderson
Address 74847 0
Mater Health Services
Evidence in Practice Unit
Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country 74847 0
Australia
Phone 74847 0
+61 7 3163 5368
Fax 74847 0
Email 74847 0
loretta.anderson@mater.org.au
Contact person for scientific queries
Name 74848 0
Prof Sue Kildea
Address 74848 0

Molly Wardaguga Research Centre
Asia Pacific College of Nursing and Midwifery
CHARLES DARWIN UNIVERSITY
Darwin, Northern Territory 0909 Australia
Country 74848 0
Australia
Phone 74848 0
+61 7 3163 6388
Fax 74848 0
Email 74848 0
sue.kildea@cdu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.