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Trial registered on ANZCTR


Registration number
ACTRN12616000551493
Ethics application status
Approved
Date submitted
20/04/2016
Date registered
28/04/2016
Date last updated
5/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a targeted lactation consultant-led intervention for perception of insufficient milk supply in new mothers
Scientific title
Efficacy of a targeted lactation consultant-led intervention for perception of insufficient milk supply in new mothers
Secondary ID [1] 289051 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived insufficient breastmilk supply 298482 0
Condition category
Condition code
Diet and Nutrition 298573 298573 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 298581 298581 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the first consultation, all participants will complete a perception of milk supply questionnaire. Those with perceived insufficient milk supply will receive individual targeted care provided by the lactation consultants. The advice given will include one or more of: correcting positioning and attachment, changing feeding frequency, commencing or increasing breast expression, taking domperidone, or investigation of the need of the infant for frenotomy. The time allocated for the first consultation is 2 hours. At the first consultation participants will be asked if they are willing to measure their 24-h milk profile. Those who agree will be randomised into either Group A or Group B (control). The randomisation codes will be in sealed, opaque envelopes that are opened in consecutive order only when the client has agreed to participate. Participants in Group A will measure their milk profile during one 24-hour period immediately after their first visit with the lactation consultant, and then again after 2-4 weeks of following the advice of the lactation consultant. They will then complete a second perception of milk supply questionnaire. All participants will attend the second (follow-up) consultation and questioned regarding compliance with advice given. For the 24-h milk profile, participants are loaned a set of BabyWeigh scales to weigh the baby in normal clothes before and after each breastfeed or supplementary feed. This is done in the participant's own home for 24 hours. The weights are entered on a secure website. Participants will also be asked to measure and enter the amount of any breastmilk expressed during that time
Intervention code [1] 294538 0
Treatment: Other
Comparator / control treatment
Participants in Group B (control) will receive individual targeted care provided by the lactation consultants, identical to the intervention group. After following the advice of the lactation consultant for 2-4 weeks they will complete a second perception of milk supply questionnaire. They will then measure their milk profile (milk production) during one 24-hour period.
Control group
Active

Outcomes
Primary outcome [1] 298067 0
The questionnaire, called "Milk supply questionnaire" was designed specifically for this study. It takes the form of statements for which the participant can choose between: strongly agree, agree, unsure, disagree and strongly disagree. The statements are: 1) I think I produce enough milk for my baby, 2) my baby is: a) growing well, b) has enough wet nappies, c) has enough soiled nappies, d) is normally alert, e) is well attached during breastfeeding, f) sucks well during breastfeeding, g) appears satisfied after breastfeeds, h) feeds too often, g) feeds too quickly, h) needs supplementary infant formula; 3) my breasts: a) feel full before feeds, b) feel soft after feeds, c) feel empty in the afternoon or evening. The outcome measure will be changes in frequencies of Likert scale responses to these statements that may contribute to the perception of insufficient milk supply.
Timepoint [1] 298067 0
The questionnaire will be administered before the initial consultation (baseline) and again 2-4 weeks after following the advice of the lactation consultant
Secondary outcome [1] 323079 0
The secondary outcome will be a change in milk production. This is measured by the mothers using BabyWeigh scales to weigh their babies at home in normal clothes before and after each breastfeed or supplementary feed, and measure the amount of any breastmilk expressed for a period of 24 hours.
Timepoint [1] 323079 0
Group A. Milk production will be measured immediately following consultation with the lactation consultant and again 2-4 weeks after following the advice of the lactation consultant (prior to the second perception questionnaire. Group B. Milk production will be measured 2-4 weeks after following the advice of the lactation consultant (following the second perception questionnaire).

Eligibility
Key inclusion criteria
Mothers of infants less than 6 months old who are exclusively, fully or partially breastfeeding and perceive that they have an insufficient milk supply will be included. This will be determined by their response to the first question of the "Milk supply questionnaire" "I think I produce enough milk for my baby". If the response is "disagree" or "strongly disagree" they will be considered to have a perception of insufficient milk supply.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers and infants who are sick or would be unable to complete a background questionnaire

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation codes will be placed in sealed opaque envelopes that will only be opened after participation has been agreed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measures for the two groups will be changes in frequencies of Likert scale responses to the 16 factors that may contribute to this perception. Changes in perceptions from before to 2-4 weeks after receiving targeted care will be tested using Fisher’s exact test. We have previously observed a positive change for 40% of participants in perception between assessments. We will be able to detect a significant difference if we recruit 30 participants in each group and there is a change in perception for 30% of the participants.
The significance of any change in total milk production from immediately receiving targeted advice and 2-4 weeks after following that advice will be assessed using paired t-test. In order to be able to detect a physiologically significant difference of 100 mL between the first and second measurements with 80% (Type I error rate a=0.05) data from 30 participants who have completed both measurements will need to be analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2016
Actual
25/08/2016
Date of last participant enrolment
Anticipated
12/11/2018
Actual
Date of last data collection
Anticipated
12/12/2018
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5646 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 13099 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 293430 0
University
Name [1] 293430 0
The University of Western Australia
Country [1] 293430 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 292249 0
Hospital
Name [1] 292249 0
King Edward Memorial Hospital for Women
Address [1] 292249 0
374 Bagot Rd, Subiaco WA 6008
Country [1] 292249 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294874 0
Women and Newborn Health Service
Ethics committee address [1] 294874 0
Ethics committee country [1] 294874 0
Australia
Date submitted for ethics approval [1] 294874 0
29/03/2016
Approval date [1] 294874 0
23/05/2016
Ethics approval number [1] 294874 0
2016055EW

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

Contacts
Principal investigator
Name 65302 0
Dr Jacqueline Kent
Address 65302 0
Hartmann Human Lactation Research Group, School of Chemistry and Biochemistry, The University of Western Australia, M310, 35 Stirling Hwy, Crawley WA 6009
Country 65302 0
Australia
Phone 65302 0
+61 8 6488 1208
Fax 65302 0
+61 8 6488 7086
Email 65302 0
Jacqueline.Kent@uwa.edu.au
Contact person for public queries
Name 65303 0
Jacqueline Kent
Address 65303 0
Hartmann Human Lactation Research Group, School of Molecular Sciences, The University of Western Australia, M310, 35 Stirling Hwy, Crawley WA 6009
Country 65303 0
Australia
Phone 65303 0
+61 8 6488 1208
Fax 65303 0
+61 8 6488 7086
Email 65303 0
Jacqueline.Kent@uwa.edu.au
Contact person for scientific queries
Name 65304 0
Jacqueline Kent
Address 65304 0
Hartmann Human Lactation Research Group, School of Chemistry and Biochemistry, The University of Western Australia, M310, 35 Stirling Hwy, Crawley WA 6009
Country 65304 0
Australia
Phone 65304 0
+61 8 6488 1208
Fax 65304 0
+61 8 6488 7086
Email 65304 0
Jacqueline.Kent@uwa.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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