The Effectiveness of Proactive Telephone Support Provided to Breastfeeding Mothers of Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01806480|
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : January 16, 2017
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 or disease||Intervention/treatment||Phase|
|Breastfeeding Quality of Life Parental Stress Attachment||Behavioral: Person-centred proactive breastfeeding telephone support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||493 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effectiveness of Proactive Telephone Support Provided to Breastfeeding Mothers of Preterm Infants - a Randomized Controlled Trial|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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.
- Exclusive breastfeeding [ Time Frame: at 8 weeks post discharge ]Exclusive breastfeeding = only providing breast milk with the exception of medicines and vitamins, regardless of method (breast, bottle, other)
- Breastfeeding [ Time Frame: at 8 weeks postdischarge and at 6 months of infant's postnatal age ]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 ]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 ]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 ]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 ]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 ]
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 ]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 ]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 ]Infant's well-being is measured through questions to mothers and partners
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806480
|Neonatal Intensive Care Unit, Karlstad Hospital|
|Karlstad, Värmland, Sweden, 65185|
|Neonatal Intensive Care Unit, Falu Hospital|
|Falun, Sweden, 79182|
|Neonatal Intensive care Unit, Skaraborgs Hospital Skövde|
|Skövde, Sweden, 54185|
|Neonatal Intensive Care Unit, Sunderbyns Hospital|
|Sunderbyn, Sweden, 97180|
|Neonatal Intensive Care Unit Trollhättan|
|Trollhättan, Sweden, 46185|
|Neonatal Intensive Care Unit, Örebro University Hospital|
|Örebro, Sweden, 70185|
|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|