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

NCT01806480 | Completed

• 2 other identifiers: AST2013RFR-215401
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Breastfeeding, Preterm Infant, Neonatal Care, Support, Mothers.

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding

  Exclusive breastfeeding = only providing breast milk with the exception of medicines and vitamins, regardless of method (breast, bottle, other)

  at 8 weeks post discharge

Secondary Outcomes (9)

• Breastfeeding

  at 8 weeks postdischarge and at 6 months of infant's postnatal age

• Parental stress in mothers and partners

  8 weeks post discharge and at 6 months of infant's postnatal age

• Quality of life in mothers and partners

  at 8 weeks post discharge and at 6 months of infant's postnatal age

• Attachment

  at 8 weeks post discharge and at 6 months of infant's postnatal age

• Mothers satisfaction with breastfeeding

  at 8 weeks post discharge and at 6 months of infant's postnatal age

Study Arms (2)

Person-centred proactive breastfeeding telephone support

EXPERIMENTAL

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 reactive breastfeeding telephone support

NO INTERVENTION

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.

Interventions

Person-centred proactive breastfeeding telephone support BEHAVIORAL

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

Person-centred proactive breastfeeding telephone support

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Center for Clinical Research Dalarna, Sweden: collaborator
• Uppsala-Örebro Regional Research Council: collaborator
• Örebro County Council: collaborator
• The Swedish Association of Health Professionals: collaborator
• Pediatric Department Falu Hospital Sweden: collaborator

Study Sites (6)

Neonatal Intensive Care Unit, Karlstad Hospital

Karlstad, Värmland County, 65185, Sweden

Location

Neonatal Intensive Care Unit, Falu Hospital

Falun, 79182, Sweden

Location

Neonatal Intensive Care Unit, Örebro University Hospital

Örebro, 70185, Sweden

Location

Neonatal Intensive care Unit, Skaraborgs Hospital Skövde

Skövde, 54185, Sweden

Location

Neonatal Intensive Care Unit, Sunderbyns Hospital

Södra Sunderbyn, 97180, Sweden

Location

Neonatal Intensive Care Unit Trollhättan

Trollhättan, 46185, Sweden

Location

Related Publications (5)

• Ericson J, Lampa E, Flacking R. Breastfeeding satisfaction post hospital discharge and associated factors - a longitudinal cohort study of mothers of preterm infants. Int Breastfeed J. 2021 Mar 25;16(1):28. doi: 10.1186/s13006-021-00374-4.

  PMID: 33766069 DERIVED

• Palmer L, Ericson J. A qualitative study on the breastfeeding experience of mothers of preterm infants in the first 12 months after birth. Int Breastfeed J. 2019 Aug 1;14:35. doi: 10.1186/s13006-019-0229-6. eCollection 2019.

  PMID: 31388343 DERIVED

• Ericson J, Eriksson M, Hoddinott P, Hellstrom-Westas L, Flacking R. Breastfeeding and risk for ceasing in mothers of preterm infants-Long-term follow-up. Matern Child Nutr. 2018 Oct;14(4):e12618. doi: 10.1111/mcn.12618. Epub 2018 May 7.

  PMID: 29733102 DERIVED

• Ericson J, Flacking R, Udo C. Mothers' experiences of a telephone based breastfeeding support intervention after discharge from neonatal intensive care units: a mixed-method study. Int Breastfeed J. 2017 Dec 19;12:50. doi: 10.1186/s13006-017-0142-9. eCollection 2017.

  PMID: 29270208 DERIVED

• Ericson J, Eriksson M, Hellstrom-Westas L, Hagberg L, Hoddinott P, Flacking R. The effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants: study protocol for a randomized controlled trial. BMC Pediatr. 2013 May 10;13:73. doi: 10.1186/1471-2431-13-73.

  PMID: 23663521 DERIVED

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Renée Flacking, PhD

  Uppsala University, Sweden

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Locations

SE (6)