The effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants: study protocol for a randomized controlled trial

Jenny Ericson, Mats Eriksson, Lena Hellström-Westas, Lars Hagberg, Pat Hoddinott, Renée Flacking, Jenny Ericson, Mats Eriksson, Lena Hellström-Westas, Lars Hagberg, Pat Hoddinott, Renée Flacking

Abstract

Background: Although 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/design: A 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.

Discussion: This 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 registration: ClinicalTrials.gov NCT01806480.

Figures

Figure 1
Figure 1
Flowchart on the progress of the study.

References

    1. World Health Organization. Global Strategy for Infant and Young Child Feeding. Geneva: WHO; 2003.
    1. Renfrew MJ, McCormick FM, Wade A, Quinn B, Dowswell T. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2012;5 CD001141.
    1. Dennis CL, Kingston D. A systematic review of telephone support for women during pregnancy and the early postpartum period. J Obstet Gynecol Neonatal Nurs. 2008;37:301–314.
    1. Schmied V, Beake S, Sheehan A, McCourt C, Dykes F. Women's perceptions and experiences of breastfeeding support: a metasynthesis. Birth. 2011;38:49–60.
    1. McCormack B, Dewing J, Breslin L, Coyne-Nevin A, Kennedy K, Manning M, Peelo-Kilroe L, Tobin C, Slater P. Developing person-centred practice: nursing outcomes arising from changes to the care environment in residential settings for older people. Int J Older People Nurs. 2010;5:93–107.
    1. McCormack B, McCance T. Person-centred nursing: theory, models and methods. Oxford: Blackwell Publishing; 2010.
    1. Bartick M, Reinhold A. The burden of suboptimal breastfeeding in the United States: a pediatric cost analysis. Pediatrics. 2010;125:e1048–1056.
    1. Renfrew M, Pokhrel S, Quigley M, McCormick F, Fox-Rushby J, Dodds R, Duffy S, Trueman P, Williams A. Preventing disease and saving resources: the potential contribution of increasing breastfeeding rates in the UK. Report commissioned by Unicef, UK, Oct 2012.
    1. American Academy of Pediatrics. Breastfeeding and the use of human milk. Pediatrics. 2012;129:827–841.
    1. Schanler RJ. Mother's own milk, donor human milk, and preterm formulas in the feeding of extremely premature infants. J Pediatr Gastroenterol Nutr. 2007;45(Suppl 3):S175–177.
    1. Schanler RJ. Outcomes of human milk-fed premature infants. Semin Perinatol. 2011;35:29–33.
    1. Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006;118:e115–123.
    1. The Organisation for Economic Co-operation and Development. Comparative child well-being across the OECD. Doing better for children 2009. 2009.
    1. Flacking R, Nyqvist KH, Ewald U. Effects of socioeconomic status on breastfeeding duration in mothers of preterm and term infants. Eur J Public Health. 2007;17:579–584.
    1. Perrella SL, Williams J, Nathan EA, Fenwick J, Hartmann PE, Geddes DT. Influences on breastfeeding outcomes for healthy term and preterm/sick infants. Breastfeed Med. 2012;7:255–261.
    1. Bonet M, Blondel B, Agostino R, Combier E, Maier RF, Cuttini M, Khoshnood B, Zeitlin J. Variations in breastfeeding rates for very preterm infants between regions and neonatal units in Europe: results from the MOSAIC cohort. Arch Dis Child Fetal Neonatal Edition. 2011;96:450–452.
    1. Akerstrom S, Asplund I, Norman M. Successful breastfeeding after discharge of preterm and sick newborn infants. Acta Paediatr. 2007;96:1450–1454.
    1. Ericson J, Flacking R. Estimated breastfeeding to support breastfeeding in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2013;42:29–37.
    1. Flacking R, Ewald U, Wallin L. Positive effect of kangaroo mother care on long-term breastfeeding in very preterm infants. J Obstet Gynecol Neonatal Nurs. 2011;40:190–197.
    1. Flacking R, Dykes F, Ewald U. The influence of fathers' socioeconomic status and paternity leave on breastfeeding duration: a population-based cohort study. Scand J Public Health. 2010;38:337–343.
    1. Flacking R, Wallin L, Ewald U. Perinatal and socioeconomic determinants of breastfeeding duration in very preterm infants. Acta Paed. 2007;96:1126–1130.
    1. Ostlund A, Nordstrom M, Dykes F, Flacking R. Breastfeeding in preterm and term twins–maternal factors associated with early cessation: a population-based study. J Hum Lact. 2010;26:235–241.
    1. Marmot M. Status Syndrome. London: Bloomsbury Publishing Plc; 2004.
    1. Flacking R, Ewald U, Nyqvist KH, Starrin B. Trustful bonds: A key to "becoming a mother" and to reciprocal breastfeeding. Stories of mothers of very preterm infants at a neonatal unit. Soc Sci Med. 2006;62:70–80.
    1. Bruschweiler Stern N. Early emotional care for mothers and infants. Pediatrics. 1998;102:1278–1281.
    1. Fenwick J, Barclay L, Schmied V. Craving closeness: a grounded theory analysis of women's experiences of mothering in the Special Care Nursery. Women Birth. 2008;21:71–85.
    1. Lupton D, Fenwick J. 'They've forgotten that I'm the mum': constructing and practising motherhood in special care nurseries. Soc Sci Med. 2001;53:1011–1021.
    1. Flacking R, Ewald U, Starrin B. "I wanted to do a good job": Experiences of becoming a mother and breastfeeding in mothers of very preterm infants after discharge from a neonatal unit. Soc Sci Med. 2007;64:2405–2416.
    1. Brett J, Staniszewska S, Newburn M, Jones N, Taylor L. A systematic mapping review of effective interventions for communicating with, supporting and providing information to parents of preterm infants. BMJ Open. 2011;1:e000023.
    1. Murdoch MR, Franck LS. Gaining confidence and perspective: a phenomenological study of mothers' lived experiences caring for infants at home after neonatal unit discharge. J Adv Nurs. 2012;68:2008–2020.
    1. Purdy IB, Singh N, Le C, Bell C, Whiteside C, Collins M. Biophysiologic and social stress relationships with breast milk feeding pre- and post-discharge from the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2012;41:347–357.
    1. Lopez GL, Anderson KH, Feutchinger J. Transition of premature infants from hospital to home life. Neonatal Netw. 2012;31:207–214.
    1. Hoddinott P, Craig LC, MacLennan G, Boyers D, Vale L. The FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas. BMJ Open. 2011;2:000652.
    1. Hoddinott P, Craig LC, MacLennan G, Boyers D, Vale L. Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas. BMJ Open. 2012;2:001039.
    1. Stark AR. Levels of neonatal care. Pediatrics. 2004;114:1341–1347.
    1. Ostberg M, Hagekull B, Wettergren S. A measure of parental stress in mothers with small children: dimensionality, stability and validity. Scand J Psychol. 1997;38:199–208.
    1. Abidin RR. Parenting Stress Index: Professional Manual. 3. Odessa, FL: Psychological Assessment Resources, Inc.; 1995.
    1. Braizer J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21:271–292.
    1. Condon JT. The assessment of antenatal emotional attachment: development of a questionnaire instrument. Br J Med Psychol. 1993;66(Pt 2):167–183.
    1. Leff EW, Jefferis SC, Gagne MP. The development of the Maternal Breastfeeding Evaluation Scale. J Hum Lact. 1994;10:105–111.
    1. Brown H, Prescott R. Applied mixed model in medicine. 2. Oxford: Wiley-Blackwell; 2006.
    1. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24:105–112.
    1. Drummond MF, Schulper MJ, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. 3. Oxford: Oxford University Press; 2005.
    1. Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey–I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995;41:1349–1358.
    1. Chung M, Raman G, Trikalinos T, Lau J, Ip S. Interventions in primary care to promote breastfeeding: an evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149:565–582.
    1. Sikorski J, Renfrew MJ, Pindoria S, Wade A. Support for breastfeeding mothers: a systematic review. Paediatr Perinat Epidemiol. 2003;17:407–417.
    1. Chung M, Ip S, Yu W, Raman G, Trikalinos T, DeVine D, Lau J. Interventions in Primary Care to Promote Breastfeeding: A Systematic Review. Syntheses USPSTFE, 2010/08/20 edn: Agency for Healthcare Research and Quality (US) 2008.

Source: PubMed

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