Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001225202
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
20/07/2018
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does post-natal breastfeeding support improve rates of breastfeeding?
Scientific title
Randomized, controlled trial of a postnatal lactation consultant intervention on duration of breastfeeding up to 6 months
Secondary ID [1] 295493 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast feeding practices 308761 0
Condition category
Condition code
Reproductive Health and Childbirth 307692 307692 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: Lactation Consultant (LC) Services

-Participants assigned to this group will receive special intervention in addition to the standard of care.
-A lactation consultant will visit them to introduce herself prior to discharge from the postnatal ward.
-They will receive regular phone/text communication from the lactation consultant, especially during the early period within 4 weeks of giving birth
-A lactation consultant with minimum 10 years experience will conduct all phone calls to recruited individuals
-Communications with the lactation consultant will seek to identify and solve breastfeeding difficulties, with referral of mothers to the breastfeeding clinic if required.
-Subjects will also be asked to report on their breastfeeding progress (ie whether they have continued to exclusively breastfeeding, are now hybrid breastfeeding, or have switched to formula feeding).
-Contact will be made over the phone at post-natal dates: 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months, and 6 months
-Participants who can not be reached by phone the first time will be left a voicemail, sent a text message, and follow-up calls will be an additional two times that week before they are classified as 'lost to follow-up'
Intervention code [1] 301817 0
Behaviour
Comparator / control treatment
CONTROL: Standard of care

-These subjects will receive routine antenatal care, care during the delivery as well as post-birth obstetric care according to best practice guidelines. This includes the option to attend a voluntary breastfeeding class prior to birthing your baby, post-birth breastfeeding clinic, and the services of a lactation consultant if you wish to consult with them.
-The lactation consultant will visit these subjects to introduce herself prior to discharge from the postnatal ward
-These subjects will be contacted by phone after 4 weeks, 3 months and 6 months for a report on their breastfeeding progress (ie whether they have continued to exclusively breastfeeding, are now hybrid breastfeeding, or have switched to formula feeding).
-Participants who can not be reached by phone the first time will be left a voicemail, sent a text message, and follow-up calls will be an additional two times that week before they are classified as 'lost to follow-up'
Control group
Active

Outcomes
Primary outcome [1] 306733 0
Outcome: Rate of Exclusive Breastfeeding
-Recorded during telephone interview with Lactation Consultant based on patient response to a direct query about current breastfeeding practice
-Measured at 1 month, 3 months, and 6months
Timepoint [1] 306733 0
The primary outcome was measured at post natal dates: 1 month, 3-months, and 6-months.
The 6-month assessment was the primary time-point.
Secondary outcome [1] 349372 0
Overall rate of breastfeeding (including hybrid breastfeeding)
-Recorded during telephone interview with Lactation Consultant based on patient response to a direct query about current breastfeeding practice
-Measured at 1 month, 3 months, and 6months.
Timepoint [1] 349372 0
The secondary outcome was measured at post-natal dates: 1 month, 3-months, and 6-months.
The 6-month assessment was the primary time point.

Eligibility
Key inclusion criteria
Participants must:
• be breastfeeding or intending to breastfeed at discharge
• have no illness that would make breastfeeding success difficult
• baby is more than 36 weeks gestation at the time of delivery
• be able to communicate in English.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Current maternal treatment with medications that are contraindicated with breastfeeding

Study design
Purpose of the study
Educational / counselling / training
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)
Simple randomisation using a randomisation table created by computer software
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
A statistical power calculation was performed and it was determined that a sample size of 700 patients would be required to achieve 80% statistical power.

An independent t-test will be performed to compare breastfeeding rates between the control and intervention groups.
A Pearson or Spearmans correlation will be applied to determine the strength of association between potential parametric or non-parametric explanatory variables with the clinical outcome. A multiple linear regression will also be performed to determine whether certain demographic or clinical factors may have also contributed to rate/duration of breastfeeding.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2018
Date of last participant enrolment
Anticipated
30/08/2019
Actual
19/09/2019
Date of last data collection
Anticipated
28/02/2020
Actual
30/03/2020
Sample size
Target
700
Accrual to date
Final
765
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11437 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 23447 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 300081 0
Charities/Societies/Foundations
Name [1] 300081 0
Northern Health Foundation
Country [1] 300081 0
Australia
Primary sponsor type
Individual
Name
Professor Wei Qi Fan
Address
Northern Health
185 Cooper Street,
Epping, VIC, 3076
Country
Australia
Secondary sponsor category [1] 299480 0
None
Name [1] 299480 0
na
Address [1] 299480 0
na
Country [1] 299480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300928 0
Austin Health Human Research Ethics Committee [EC00204]
Ethics committee address [1] 300928 0
Ethics committee country [1] 300928 0
Australia
Date submitted for ethics approval [1] 300928 0
Approval date [1] 300928 0
17/10/2017
Ethics approval number [1] 300928 0
LNR/17/Austin/371

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

Contacts
Principal investigator
Name 85310 0
A/Prof Wei Qi Fan
Address 85310 0
Northern Hospital
185 Cooper St, Epping VIC 3076
Country 85310 0
Australia
Phone 85310 0
+61 3 8405 8171
Fax 85310 0
Email 85310 0
[email protected]
Contact person for public queries
Name 85311 0
Wei Qi Fan
Address 85311 0
Northern Hospital
185 Cooper St, Epping VIC 3076
Country 85311 0
Australia
Phone 85311 0
+61 3 8405 8171
Fax 85311 0
Email 85311 0
[email protected]
Contact person for scientific queries
Name 85312 0
Wei Qi Fan
Address 85312 0
Northern Hospital
185 Cooper St, Epping VIC 3076
Country 85312 0
Australia
Phone 85312 0
+61 3 8405 8171
Fax 85312 0
Email 85312 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseWeekly Proactive Telephone Breastfeeding Standard Care by Lactation Consultants in the First Month Postpartum Prolongs Breastfeeding for Up to 6 Months.2023https://dx.doi.org/10.3390/nu15092075
N.B. These documents automatically identified may not have been verified by the study sponsor.