Clinical trial NCT01893736: Professional Breastfeeding Support Intervention
Official title: A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
professional support
postnatal
interventions
exclusive breastfeeding
randomized controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 722
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence of any and exclusive breastfeeding
timeFrame: 1 month postpartum
measure: Prevalence of any and exclusive breastfeeding
timeFrame: 2 months postpartum
measure: Prevalence of any and exclusive breastfeeding
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Median duration of breastfeeding
timeFrame: 6 month postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Marie Tarrant, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.