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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.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000769381
Acronym
PREM Trial
Enrollment
31
Registered
2017-05-25
Start date
2018-02-15
Completion date
2019-03-19
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ho

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.

Sponsors

Sue Kildea
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026