Abstract
BackgroundAlthough breast milk has numerous benefits for infants’ development, with greater 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 intervention after discharge from NICU is expected to promote mothers’ sense of trust in their own capacity and thereby facilitate breastfeeding.Methods/designA multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. Primary outcome: proportion of mothers exclusively breastfeeding at eight weeks after discharge. Secondary outcomes: proportion of breastfeeding (exclusive, partial, none and method of feeding), 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. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff.DiscussionThis paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.Trial registrationNCT01806480
Highlights
Breast milk has numerous benefits for infants’ development, with greater effects in those born preterm, mothers of preterm infants have shorter breastfeeding duration than mothers of term infants
This paper presents the rationale, study design and protocol for a randomized controlled trial (RCT) providing person-centred proactive telephone support to mothers of preterm infants
This paper outlines a RCT designed for mothers of preterm infants to improve breastfeeding rates, mothers’ breastfeeding satisfaction and attachment, and parents’ health and wellbeing
Summary
This paper outlines a RCT designed for mothers of preterm infants to improve breastfeeding rates, mothers’ breastfeeding satisfaction and attachment, and parents’ health and wellbeing. Intervention and control groups will be able to access reactive support which is not standard practice This strategy reduces the risk of the Hawthorne effect (motivational effect of the interest being shown in them) as all included mothers will be eligible to telephone the BST for support and outcome data will be measured identically for all groups. A strength in this study is that data collection will take place in four hospitals in different counties, which will a) increase the scientific quality by reducing the risk of recruitment bias, b) facilitate participant recruitment within a feasible time, c) enable comparisons of both outcomes and intervention delivery process between different teams and NICU contexts which increases the generalisability to other settings. RF, ME, LHW are involved with PhD supervision of JE on this project
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