ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast feeding practices

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

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]

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]

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]

The Northern Hospital - Epping

Recruitment postcode(s) [1]

3076 - Epping

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Northern Health Foundation

Address [1]

Northern Health Foundation
185 Cooper St,
Epping VIC 3076

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee [EC00204]

Ethics committee address [1]

Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/10/2017

Ethics approval number [1]

LNR/17/Austin/371

Summary

Brief summary

Despite awareness of the advantages of breastfeeding, the rates often fall short of expected practice. In the Whittlesea area alone, the initial rate of breastfeeding is very high at >94% of newborn infants. However, rates drop by 30% at 8 weeks (2 months) post-birth.

At The Northern Hospital, there are 2 support systems in place. This is in line with UNICEF and the World Health Organization (WHO) breastfeeding practices. First, all expecting mothers are invited to attend breastfeeding seminars prior to the delivery of their newborns. Secondly, TNH also has a breastfeeding clinic that runs daily and mothers can refer themselves to this clinic when and if they feel the need. However, there is a perception that once the mothers leave hospital, there is lack of breastfeeding support, so we feel that we need to do more to help promote breastfeeding.

Our hypothesis was that breastfeeding rates can be improved with additional support and education from a lactation consultant. The study aims to determine if additional support for breastfeeding mothers after they leave hospital improves rates of breastfeeding.

In this randomized controlled trial, participants will be randomized to either an intervention or  a control group. In the intervention group, a LACTATION CONSULTANT will provide active communication and assistance via telephone to breastfeeding mothers, especially during the first 4 weeks after discharge and then again after 3 months and 6 months.
In the control group, a LACTATION CONSULTANT will contact breastfeeding mothers via telephone after 1 month, 3 months, and 6 months to ask about breastfeeding activity/practices.

At the end of the study, we will compare the rates of breastfeeding in mothers who received the intervention compared to the control group and determine whether additional assistance from lactation consultants is associated with longer breastfeeding duration.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Wei Qi Fan

Address

Northern Hospital
185 Cooper St, Epping VIC 3076

Country

Australia

Phone

+61 3 8405 8171

Fax

WeiQi.Fan@nh.org.au

Contact person for public queries

Name

Wei Qi Fan

Address

Northern Hospital
185 Cooper St, Epping VIC 3076

Country

Australia

Phone

+61 3 8405 8171

Fax

WeiQi.Fan@nh.org.au

Contact person for scientific queries

Name

Wei Qi Fan

Address

Northern Hospital
185 Cooper St, Epping VIC 3076

Country

Australia

Phone

+61 3 8405 8171

Fax

WeiQi.Fan@nh.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Weekly Proactive Telephone Breastfeeding Standard Care by Lactation Consultants in the First Month Postpartum Prolongs Breastfeeding for Up to 6 Months.	2023	https://dx.doi.org/10.3390/nu15092075

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically