The Effectiveness of Proactive Telephone Support Provided to Breastfeeding Mothers of Preterm Infants

Summary

Although breast milk has numerous benefits for infants' development, with heightened effects in those born preterm (at \< 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support to breastfeeding mothers after discharge from NICU is expected to promote mothers' sense of trust in their own capacity and thereby facilitate breastfeeding. We hypothesize that proactive (health service initiated) telephone breastfeeding support offered to mothers of preterm infants after hospital discharge is more effective than reactive (mother initiated, and defined as usual care) telephone support at increasing the proportion of mothers who are exclusively breastfeeding 8 weeks after discharge.

A multicentre randomized controlled blinded trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding to mothers of preterm infants. Mothers will be informed about the study before discharge. Participating mothers will be randomized to either a control group or intervention group, immediately after discharge. Mothers will be notified to what group they have been randomized to through phone call or sms, depending on mother's preferences.

* Control group: person-centred reactive telephone support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge.
* Intervention group: reactive support AND person-centred proactive telephone support in which the breastfeeding support team phones the mother daily for up to 14 days after hospital discharge.

A stratified block randomization will be used; group allocation will be done on high or low SES (i.e. educational level) and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. The data will be collected at eight weeks after discharge and at six months of infant's postnatal age using telephone interviews and questionnaires. Primary outcome is exclusive breastfeeding at eight weeks after discharge from the NICU. Secondary outcomes are breastfeeding (i.e. exclusive, partial, none and method), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. A qualitative evaluation of experiences of providing/receiving the intervention will also be performed with mothers and staff respectively.

Conditions

• Breastfeeding
• Quality of Life
• Parental Stress
• Attachment

Interventions

BEHAVIORAL

Person-centred proactive breastfeeding telephone support

Person-centred care is a model of care, which comprise components such as: building mutual trust and understanding; treating the person as an individual; respect the rights for the person, sharing decision-making, providing holistic care and developing therapeutic relationships. Furthermore, the care provider should have a sympathetic presence and show an engagement

Sponsors & Collaborators

• Center for Clinical Research Dalarna, Sweden

  collaborator OTHER

• Uppsala-Örebro Regional Research Council

  collaborator OTHER

• Örebro County Council

  collaborator OTHER_GOV

• The Swedish Association of Health Professionals

  collaborator UNKNOWN

• Pediatric Department Falu Hospital Sweden

  collaborator UNKNOWN

• Uppsala University

  lead OTHER

Principal Investigators

• Renée Flacking, PhD · Uppsala University, Sweden

• Mats Eriksson, Ass Professor · Centre for Health Care Sciences, Örebro University Hospital, Örebro, Sweden

• Lena Hellström-Westas, Professor · Uppsala University, Sweden

• Lars Hagberg, PhD · Centre for Health Care Sciences, Örebro University Hospital, Örebro, Sweden

• Pat Hoddinott, Professor · Nursing, Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, Scotland

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

36 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Sweden

Study Locations