Professional Breastfeeding Support Intervention

Breastfeeding Clinical Trial

Official title:

A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893736
• Other study ID #: PBFS-1
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: March 12, 2015
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.

Description:

The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.

The primary hypotheses are:

1. Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);

2. The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;

The secondary hypotheses are:

1. The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;

2. The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: March 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. delivers at participating trial site,

2. primiparous,

3. intends to breastfeed,

4. 18 years of age or older,

5. has singleton pregnancy,

6. Cantonese speaking,

7. Hong Kong resident for more than one year,

8. no serious medical or obstetrical complications

Exclusion Criteria:

1. < 37 weeks gestation,

2. an Apgar score < 8 at five minutes,

3. a birth weight < 2500 grams,

4. born with any severe medical conditions or congenital malformations,

5. is placed in the special care nursery for more than 48 hours after delivery,

6. is placed in the intensive care nursery after delivery,

7. not entitled to health benefits in Hong Kong (NEP).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• In-hospital professional support
In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
• Postpartum telephone follow-up support
Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Fu IC, Fong DY, Heys M, Lee IL, Sham A, Tarrant M. Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. BJOG. 2014 Dec;121(13):1673-83. doi: 10.1111/1471-0528.12884. Epub 2014 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of any and exclusive breastfeeding	Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum	1 month postpartum	No
Primary	Prevalence of any and exclusive breastfeeding	Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum	2 months postpartum	No
Primary	Prevalence of any and exclusive breastfeeding	Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum	3 months postpartum	No
Secondary	Median duration of breastfeeding	The median duration of any breastfeeding and the median duration of exclusive breastfeeding.	6 month postpartum	No