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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Uppsala University
Sponsor:
Collaborators:
Centre for Clinical Research Dalarna Sweden
Regional Research Council Örebro and Uppsala Sweden
Örebro County Council
The Swedish Association of Health Professionals
Pediatric Department Falu Hospital Sweden
Information provided by (Responsible Party):
Renée Flacking, Uppsala University
ClinicalTrials.gov Identifier:
NCT01806480
First received: March 5, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breastfeeding
Quality of Life
Parental Stress
Attachment
Behavioral: Person-centred proactive breastfeeding telephone support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Proactive Telephone Support Provided to Breastfeeding Mothers of Preterm Infants - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Exclusive breastfeeding [ Time Frame: at 8 weeks post discharge ] [ Designated as safety issue: No ]
    Exclusive breastfeeding = only providing breast milk with the exception of medicines and vitamins, regardless of method (breast, bottle, other)


Secondary Outcome Measures:
  • Breastfeeding [ Time Frame: at 8 weeks postdischarge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    At 8 weeks post discharge: any breastfeeding; method of feeding (breast, bottle or other) At 6 months postnatal age: breastfeeding (exclusive, partial, no and method of feeding)

  • Parental stress in mothers and partners [ Time Frame: 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Measured through the Swedish Parenthood Stress Questionnaire (SPSQ), an adapted version of the Parental Stress Index. It measures perceived stress in parenting in five dimensions (incompetence, role restriction, social isolation, spouse relationship and health problems)

  • Quality of life in mothers and partners [ Time Frame: at 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Measured through the Short-Form Health Survey (SF-36). It measures self reported physical and mental health

  • Attachment [ Time Frame: at 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Attachment between the infant and the mother will be measured through the Maternal Postnatal Attachment Scale (MPAS). The scale comprise mothers' emotional response to their infants and dimensions relating to mother-infant attachment

  • Mothers satisfaction with breastfeeding [ Time Frame: at 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Satisfaction with breastfeeding will be measured through the Maternal Breastfeeding Evaluation Scale Measure (MBFES), which measures mothers' satisfaction with breastfeeding

  • Cost-effectiveness [ Time Frame: Expected average of 15 months ] [ Designated as safety issue: No ]

    Incremental costs of proactive breastfeeding support will be compared to incremental benefits, in comparison to reactive breastfeeding support.

    Incremental costs: measured by recording the number and duration of telephone calls in both study groups.

    Incremental benefits: gained quality adjusted life years (QALYs) in parents and infants up to 6 months of infant's postnatal age


  • Infant's health [ Time Frame: at 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Infant's illnesses is measured through questions to mothers and partners.

  • Experiences of breastfeeding support [ Time Frame: at 8 weeks post discharge for all mothers and a selected group after the study period ] [ Designated as safety issue: No ]
    Mothers are asked to rate their experience of breastfeeding support in a questionnaire at 8 weeks post discharge. A selected group of mothers are also invited to participate in focus groups where they will be asked to narrate their experiences of the breastfeeding support.

  • Infant's well-being [ Time Frame: at 8 weeks post discharge and at 6 months of infant's postnatal age ] [ Designated as safety issue: No ]
    Infant's well-being is measured through questions to mothers and partners


Estimated Enrollment: 1116
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Person-centred proactive breastfeeding telephone support
Proactive breastfeeding telephone support initiated by the Breastfeeding Support Team (BST) at the NICU from which the infant is discharged. Daily phone calls from one member in the BST to the mother will be performed from day 1 until day 14 after discharge. In addition to this, the mother has the option to call someone in the BST during the same period (reactive). The telephone support will be conducted with a person-centered approach. Thus, the mother is enabled to talk about whatever feels important to her including the situation with the new infant at home and her breastfeeding. The feeding support team member should during the telephone support session: have an authentic presence, characterized by being there for the mother, having an empathic approach, taking time touching base, providing affirmation, being responsive, sharing the mother's experience and enabling a relationship.
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
No Intervention: Person-centred reactive breastfeeding telephone support
The control group (and the intervention group) will be offered the possibility to person-centred reactive telephone support initiated by the mother who can phone the feeding support team from day 1 after discharge until day 14 after discharge, between 08.00-16.00 every day. Each NICU will set up a specific telephone number for their telephone support, and schedule the members in the BST for availability. The same level of person-centeredness will be provided in both reactive and proactive telephone support.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mothers with preterm infants (< 37 gestational weeks)
  • infant admitted to one of the four selected NICUs for at least 48 hours
  • mother who breastfeed or express breast milk

Exclusion Criteria:

  • serious maternal medical or psychiatric problems at discharge
  • language problems that cannot be resolved
  • infant is transferred to another hospital/unit after discharge
  • infant that is terminally ill
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806480

Contacts
Contact: Jenny Ericson, PhD-student 46 70 7883532 jenny.ericson@ltdalarna.se
Contact: Renée Flacking, PhD 46 23 778541 renee.flacking@kbh.uu.se

Locations
Sweden
Neonatal Intensive Care Unit, Karlstad Hospital Recruiting
Karlstad, Värmland, Sweden, 65185
Contact: Jenny Ericson, PhD-student    46 70 7883532    jenny.ericson@ltdalarna.se   
Principal Investigator: Jenny Ericson, PhD-student         
Neonatal Intensive Care Unit, Falu Hospital Recruiting
Falun, Sweden, 79182
Contact: Jenny Ericson, PhD-student    46 70 7883532    jenny.ericson@ltdalarna.se   
Principal Investigator: Jenny Ericson, PhD-student         
Neonatal Intensive care Unit, Skaraborgs Hospital Skövde Recruiting
Skövde, Sweden, 54185
Contact: Jenny Ericson, PhD-student    46 70 7883532    jenny.ericson@ltdalarna.se   
Principal Investigator: Jenny Ericson, PhD-student         
Neonatal Intensive Care Unit, Sunderbyns Hospital Recruiting
Sunderbyn, Sweden, 97180
Contact: Jenny Ericson, PhD-student    46 70 7883532    jenny.ericson@ltdalarna.se   
Principal Investigator: Jenny Ericson, PhD-student         
Neonatal Intensive Care Unit, Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Jenny Ericson, PhD-student    46 70 7883532    jenny.ericson@ltdalarna.se   
Principal Investigator: Jenny Ericson, PhD-student         
Sponsors and Collaborators
Uppsala University
Centre for Clinical Research Dalarna Sweden
Regional Research Council Örebro and Uppsala Sweden
Örebro County Council
The Swedish Association of Health Professionals
Pediatric Department Falu Hospital Sweden
Investigators
Study Director: Renée Flacking, PhD Uppsala University, Sweden
Study Chair: Mats Eriksson, Ass Professor Centre for Health Care Sciences, Örebro University Hospital, Örebro, Sweden
Study Chair: Lena Hellström-Westas, Professor Uppsala University, Sweden
Study Chair: Lars Hagberg, PhD Centre for Health Care Sciences, Örebro University Hospital, Örebro, Sweden
Study Chair: Pat Hoddinott, Professor Nursing, Midwifery and Allied Health Professionals Research Unit, University of Stirling, Stirling, Scotland
  More Information

Additional Information:
No publications provided by Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renée Flacking, Senior Research Fellow, Uppsala University
ClinicalTrials.gov Identifier: NCT01806480     History of Changes
Other Study ID Numbers: AST2013, RFR-215401
Study First Received: March 5, 2013
Last Updated: April 3, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Breastfeeding, Preterm Infant, Neonatal Care, Support, Mothers.

ClinicalTrials.gov processed this record on August 20, 2014