Original Research
Donna Dowling, PhD, RN ❍ Section Editor
Acceptability and Feasibility of a Breast Milk Expression Education and Support Intervention in Mothers of Preterm Infants Marjolaine Héon, RN, PhD; Céline Goulet, RN, PhD; Carole Garofalo, DEC; Anne Monique Nuyt, MD; Emile Levy, MD, PhD ABSTRACT PURPOSE: A pilot study was conducted to assess the acceptability and feasibility of a breast milk expression education and support intervention in mothers of preterm infants and study procedures. SUBJECTS: Forty mothers of preterm infants born at less than 30 weeks of gestation. DESIGN: Pilot randomized controlled trial. METHODS: Mothers of preterm infants were randomly allocated to the breast milk expression education and support intervention or standard care. The experimental intervention encompassed a breast milk expression education session on 7 themes, telephone follow-up, and telephone helpline. MAIN OUTCOME MEASURES: Data related to the acceptability and feasibility of the intervention and study procedures were collected throughout the study. At the end of the study, mothers allocated to the experimental intervention completed a self-report questionnaire assessing the acceptability of each of the intervention components. RESULTS: It was feasible to recruit 70% of eligible mothers and retain 83% of mothers who consented to participate in the study. Mothers reported that all the intervention components were appropriate and effective in supporting their breast milk production. Although the reliability of the data collection method was demonstrated, the fidelity of the telephone follow-up faced some challenges. CONCLUSIONS: Both the intervention and study procedures were acceptable and feasible. Improvements related to the fidelity of the intervention would ensure the feasibility and internal validity of a larger-scale trial. Key Words: breastfeeding, breast milk expression, intervention, lactation, pilot study, preterm infants
A
lthough nourishing their preterm infants with breast milk can provide mothers with a sense of connection,1-3 valorization,4 and gratifica5 expressing breast milk may also translate into tion, a journey strewn with struggles.6 These mothers often encounter psychological stress,7-9 anxiety,10 and dyad separation5,11; the most challenging of all is to face insufficient breast milk production.1,12-14 Insufficient breast milk production is common among mothers of preterm infants13 and represents one of the major barriers to breastfeeding in preterm infants.15 Mothers report breast problems while expressing16 and difficulties establishing and sustaining their breast milk production.2,5 They also voice concerns with regard to their ability to maintain sufficient breast milk
production to fulfill the growing nutritional needs of their preterm infants.1,16 When initiating breast milk expression or facing difficulties establishing and maintaining sufficient breast milk production, mothers of preterm infants would like to be supported by experienced and skilled healthcare professionals.17 They perceive their counseling and assistance as the cornerstone of successful breastfeeding.18 To promote the initiation, establishment, and maintenance of a sufficient breast milk production in mothers of preterm infants, an education and support intervention was developed and evaluated through a pilot randomized clinical trial. The aim of this pilot study was to assess the acceptability and feasibility of the intervention and study procedures.
Advances in Neonatal Care • Vol. 14, No. 4 • pp. E9-E19
E9
Copyright © 2014 National Association of Neonatal Nurses. Unauthorized reproduction of this article is prohibited.
ANC-D-14-00060.indd E9
21/07/14 9:07 PM
E10
Héon et al
The following research questions guided this pilot study: (1) Are the breast milk expression education and support intervention and study procedures acceptable to mothers of preterm infants? And (2) are the breast milk expression education and support intervention and study procedures feasible?
METHODS Study Design A pilot randomized controlled trial design was conducted to evaluate the acceptability and feasibility of the breast milk education and support intervention and study procedures in mothers of preterm infants. Setting and Sample The pilot project received Research Ethics Boards approval from the Sainte-Justine University Hospital Center, Montreal, Canada, where the recruitment was initiated at the NICU on October 27, 2008, and completed on August 30, 2010. Mothers were eligible to participate in the study if they (1) had given birth to a preterm infant before 30 weeks of gestation, (2) were 18 years of age or older, and (3) had decided to breastfeed. Mothers were excluded if they (1) had opted for mixed feeding (breast milk and formula), (2) had undergone previous breast surgery, or (3) had severe physical or mental health problems impeding their participation in the pilot study. Eligible mothers were approached by the principal investigator within 24 hours after birth. The pilot study was presented and explained to them, and their informed written consents were obtained afterword.
Author Affiliations: Faculté des sciences infirmières, Université de Montréal, Québec, Canada (Drs Héon and Goulet); Quebec Nursing Intervention Research Network, Montréal, Canada (Dr Héon); Faculté de biologie et de médecine, Université de Lausanne, Switzerland (Dr Goulet); Research Centre, CHU SainteJustine, Montréal, Québec, Canada (Ms Garofalo and Drs Nuyt and Levy); Department of Nutrition, Université de Montréal, Québec, Canada (Ms Garofalo and Dr Levy); Department of Pediatrics, Université de Montréal, Québec, Canada (Dr Nuyt). Funding for this pilot study was provided by AWHONN Canada, Canadian Institutes of Health Research (CIHR), Canadian Nurses Foundation, and Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ). Financial support was provided to the principal investigator during her doctoral studies by the Canadian Institutes of Health Research (CIHR), Faculté des études supérieures et postdoctorales de l’Université de
Sample Size Forty mothers of preterm infants were recruited for this pilot study, which is a sufficient sample for a pilot study.19,20 Randomization Computerized blocked randomization and sealed opaque envelopes were used to randomly assign mothers to standard care (control group [CG]) or the breast milk expression education and support intervention (experimental group [EG]). Blinding Both participants and the lactation consultant nurse who delivered the intervention were aware of the allocated arm because of the nature of the intervention. Interventions In both groups, mothers had access to the loan of a Symphony double electric breast pump by Medela (Mississauga, Ontario, Canada) with accessories for the period of their participation in the study. In the CG, mothers received standard care, which consisted of care usually provided by perinatal and neonatal nurses to mothers of preterm infants with regard to breastfeeding. In the EG, in addition to the standard care, mothers received the breast milk expression education and support intervention (see Table 1). The intervention was delivered by 1 lactation consultant nurse and had the following 2 components: (1) a 2-hour educational component on 7 themes related to breast milk expression; and (2) a support component that comprised a telephone
Montréal, Faculté des sciences infirmières de l’Université de Montréal, Fondation CHU Sainte-Justine, Fondation de recherche en sciences infirmières du Québec (FRESIQ), Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ), Ministère de l’Éducation, du Loisir et du Sport du Québec, and Ordre des infirmières et infirmiers du Québec (OIIQ). Medela Canada offered complimentary breast pump accessory sets. The authors declare no conflict of interest. Correspondence: Marjolaine Héon, RN, PhD, Faculté des sciences infirmières, Université de Montréal, CP 6128, succursale Centreville, Montréal, Québec Canada H3C 3J7 ([email protected]). Copyright © 2014 by The National Association of Neonatal Nurses DOI: 10.1097/ANC.0000000000000113 www.advancesinneonatalcare.org
Copyright © 2014 National Association of Neonatal Nurses. Unauthorized reproduction of this article is prohibited.
ANC-D-14-00060.indd E10
21/07/14 9:07 PM
Milk Expression Education and Support Intervention
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TABLE 1. Breast Milk Education Session and Support Intervention Intervention Component
Timing
Description
Educational component Education session
Donna Dowling, PhD, RN ❍ Section Editor
Acceptability and Feasibility of a Breast Milk Expression Education and Support Intervention in Mothers of Preterm Infants Marjolaine Héon, RN, PhD; Céline Goulet, RN, PhD; Carole Garofalo, DEC; Anne Monique Nuyt, MD; Emile Levy, MD, PhD ABSTRACT PURPOSE: A pilot study was conducted to assess the acceptability and feasibility of a breast milk expression education and support intervention in mothers of preterm infants and study procedures. SUBJECTS: Forty mothers of preterm infants born at less than 30 weeks of gestation. DESIGN: Pilot randomized controlled trial. METHODS: Mothers of preterm infants were randomly allocated to the breast milk expression education and support intervention or standard care. The experimental intervention encompassed a breast milk expression education session on 7 themes, telephone follow-up, and telephone helpline. MAIN OUTCOME MEASURES: Data related to the acceptability and feasibility of the intervention and study procedures were collected throughout the study. At the end of the study, mothers allocated to the experimental intervention completed a self-report questionnaire assessing the acceptability of each of the intervention components. RESULTS: It was feasible to recruit 70% of eligible mothers and retain 83% of mothers who consented to participate in the study. Mothers reported that all the intervention components were appropriate and effective in supporting their breast milk production. Although the reliability of the data collection method was demonstrated, the fidelity of the telephone follow-up faced some challenges. CONCLUSIONS: Both the intervention and study procedures were acceptable and feasible. Improvements related to the fidelity of the intervention would ensure the feasibility and internal validity of a larger-scale trial. Key Words: breastfeeding, breast milk expression, intervention, lactation, pilot study, preterm infants
A
lthough nourishing their preterm infants with breast milk can provide mothers with a sense of connection,1-3 valorization,4 and gratifica5 expressing breast milk may also translate into tion, a journey strewn with struggles.6 These mothers often encounter psychological stress,7-9 anxiety,10 and dyad separation5,11; the most challenging of all is to face insufficient breast milk production.1,12-14 Insufficient breast milk production is common among mothers of preterm infants13 and represents one of the major barriers to breastfeeding in preterm infants.15 Mothers report breast problems while expressing16 and difficulties establishing and sustaining their breast milk production.2,5 They also voice concerns with regard to their ability to maintain sufficient breast milk
production to fulfill the growing nutritional needs of their preterm infants.1,16 When initiating breast milk expression or facing difficulties establishing and maintaining sufficient breast milk production, mothers of preterm infants would like to be supported by experienced and skilled healthcare professionals.17 They perceive their counseling and assistance as the cornerstone of successful breastfeeding.18 To promote the initiation, establishment, and maintenance of a sufficient breast milk production in mothers of preterm infants, an education and support intervention was developed and evaluated through a pilot randomized clinical trial. The aim of this pilot study was to assess the acceptability and feasibility of the intervention and study procedures.
Advances in Neonatal Care • Vol. 14, No. 4 • pp. E9-E19
E9
Copyright © 2014 National Association of Neonatal Nurses. Unauthorized reproduction of this article is prohibited.
ANC-D-14-00060.indd E9
21/07/14 9:07 PM
E10
Héon et al
The following research questions guided this pilot study: (1) Are the breast milk expression education and support intervention and study procedures acceptable to mothers of preterm infants? And (2) are the breast milk expression education and support intervention and study procedures feasible?
METHODS Study Design A pilot randomized controlled trial design was conducted to evaluate the acceptability and feasibility of the breast milk education and support intervention and study procedures in mothers of preterm infants. Setting and Sample The pilot project received Research Ethics Boards approval from the Sainte-Justine University Hospital Center, Montreal, Canada, where the recruitment was initiated at the NICU on October 27, 2008, and completed on August 30, 2010. Mothers were eligible to participate in the study if they (1) had given birth to a preterm infant before 30 weeks of gestation, (2) were 18 years of age or older, and (3) had decided to breastfeed. Mothers were excluded if they (1) had opted for mixed feeding (breast milk and formula), (2) had undergone previous breast surgery, or (3) had severe physical or mental health problems impeding their participation in the pilot study. Eligible mothers were approached by the principal investigator within 24 hours after birth. The pilot study was presented and explained to them, and their informed written consents were obtained afterword.
Author Affiliations: Faculté des sciences infirmières, Université de Montréal, Québec, Canada (Drs Héon and Goulet); Quebec Nursing Intervention Research Network, Montréal, Canada (Dr Héon); Faculté de biologie et de médecine, Université de Lausanne, Switzerland (Dr Goulet); Research Centre, CHU SainteJustine, Montréal, Québec, Canada (Ms Garofalo and Drs Nuyt and Levy); Department of Nutrition, Université de Montréal, Québec, Canada (Ms Garofalo and Dr Levy); Department of Pediatrics, Université de Montréal, Québec, Canada (Dr Nuyt). Funding for this pilot study was provided by AWHONN Canada, Canadian Institutes of Health Research (CIHR), Canadian Nurses Foundation, and Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ). Financial support was provided to the principal investigator during her doctoral studies by the Canadian Institutes of Health Research (CIHR), Faculté des études supérieures et postdoctorales de l’Université de
Sample Size Forty mothers of preterm infants were recruited for this pilot study, which is a sufficient sample for a pilot study.19,20 Randomization Computerized blocked randomization and sealed opaque envelopes were used to randomly assign mothers to standard care (control group [CG]) or the breast milk expression education and support intervention (experimental group [EG]). Blinding Both participants and the lactation consultant nurse who delivered the intervention were aware of the allocated arm because of the nature of the intervention. Interventions In both groups, mothers had access to the loan of a Symphony double electric breast pump by Medela (Mississauga, Ontario, Canada) with accessories for the period of their participation in the study. In the CG, mothers received standard care, which consisted of care usually provided by perinatal and neonatal nurses to mothers of preterm infants with regard to breastfeeding. In the EG, in addition to the standard care, mothers received the breast milk expression education and support intervention (see Table 1). The intervention was delivered by 1 lactation consultant nurse and had the following 2 components: (1) a 2-hour educational component on 7 themes related to breast milk expression; and (2) a support component that comprised a telephone
Montréal, Faculté des sciences infirmières de l’Université de Montréal, Fondation CHU Sainte-Justine, Fondation de recherche en sciences infirmières du Québec (FRESIQ), Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ), Ministère de l’Éducation, du Loisir et du Sport du Québec, and Ordre des infirmières et infirmiers du Québec (OIIQ). Medela Canada offered complimentary breast pump accessory sets. The authors declare no conflict of interest. Correspondence: Marjolaine Héon, RN, PhD, Faculté des sciences infirmières, Université de Montréal, CP 6128, succursale Centreville, Montréal, Québec Canada H3C 3J7 ([email protected]). Copyright © 2014 by The National Association of Neonatal Nurses DOI: 10.1097/ANC.0000000000000113 www.advancesinneonatalcare.org
Copyright © 2014 National Association of Neonatal Nurses. Unauthorized reproduction of this article is prohibited.
ANC-D-14-00060.indd E10
21/07/14 9:07 PM
Milk Expression Education and Support Intervention
E11
TABLE 1. Breast Milk Education Session and Support Intervention Intervention Component
Timing
Description
Educational component Education session
