A Randomized Controlled Trial - Wiley Online Library

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Jo Watson MacDonell, RN, MScN, IBCLC, Sharyn Gibbins, RN, PhD, Denise Guerriere, ... Research Centre, University of Toronto; Jo Watson MacDonell is.
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Home versus Hospital Breastfeeding Support for Newborns: A Randomized Controlled Trial Patricia McKeever, RN, PhD, Bonnie Stevens, RN, PhD, Karen-Lee Miller, MA, MSW, Jo Watson MacDonell, RN, MScN, IBCLC, Sharyn Gibbins, RN, PhD, Denise Guerriere, RN, PhD, Michael S. Dunn, MD, Peter C. Coyte, PhD ABSTRACT: Background: The advantages of breastfeeding have been well established for both mothers and their infants. Existing research reports equivocal effects of early discharge and postpartum home care on breastfeeding success. The purpose of this study was to compare the effects of breastfeeding support offered in hospital and home settings on breastfeeding outcomes and maternal satisfaction for mothers of term and near-term newborns who experienced standard or early discharge. Methods: In a randomized controlled trial with prognostic stratification for gestational age, 101 term and 37 near-term (35–37 weeks’ gestational age) mother-newborn pairs were randomized to either a standard care group (standard care and standard length of hospitalization) or an experimental group (standard hospital care with early discharge and home support from nurses who were certified lactation consultants). Data collection occurred before randomization, at discharge from hospital, and from 5 to12 days postpartum. Primary outcomes included breastfeeding rates and maternal satisfaction. Results: More mothers of term newborns in the experimental group were breastfeeding exclusively at follow-up (p ¼ 0.02) compared with the control group. No significant breastfeeding differences occurred among mothers with near-term newborns in the experimental and standard care groups. Conclusions: In-home lactation support appears to facilitate positive breastfeeding outcomes for mothers of term newborns. This may also be a beneficial model of postpartum care for mothers of near-term newborns; however, further research is required. The findings suggest implications for health caregivers and policy makers with respect to postpartum lactation and health care services. (BIRTH 29:4 December 2002) Breastfeeding provides significant nutritional and immunological advantages to term and preterm infants (1,2), and physiological, psychological, and social gains to mothers (2,3). Nonetheless, the estab-

lishment of breastfeeding in term, and especially preterm, newborns is challenging, time consuming, and resource consuming (2,4,5). In Canada, 31 percent of mothers never initiate breastfeeding (6).

Patricia McKeever is a Professor with the Faculty of Nursing, University of Toronto; Bonnie Stevens is a Professor with the Faculty of Nursing, University of Toronto; Karen-Lee Miller is a Research Associate with the Home and Community Care Evaluation and Research Centre, University of Toronto; Jo Watson MacDonell is the Director of Obstetrics for the Perinatal Program at the Sunnybrook and Women’s College Health Sciences Centre, Toronto; Sharyn Gibbins is the Head of Interdisciplinary Research, Sunnybrook and Women’s College Health Sciences Centre, Toronto; Denise Guerriere is an Assistant Professor with the Department of Health Policy, Management and Evaluation, University of Toronto; Michael S. Dunn is an Associate Professor with the Department of Paediatrics, University of Toronto; and Peter C. Coyte is a Professor

of Health Economics with the Department of Health Policy, Management and Evaluation, University of Toronto. This project was supported by a grant from the Health Transition Fund, Health Canada, Ottawa, and by a financial contribution from The Hospital for Sick Children Foundation, Toronto, Ontario, Canada. Address correspondence to Patricia McKeever, PhD, Faculty of Nursing, University of Toronto, 50 St. George Street, Toronto, Ontario, Canada, M5S 3H4.  2002 Blackwell Publishing, Inc.

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Furthermore, a recent provincial survey found that breastfeeding rates decline swiftly within 14 days of delivery (7). Early discharge, defined as leaving the hospital less than 48 hours after birth (8), may exacerbate breastfeeding difficulties (4,5,9). The trend to shorter maternity stays began as a consumer initiative, reflecting parents’ desires to leave the hospital as soon as possible after delivery, and gained acceptance as a strategy to respond to economic constraints (8,10). However, shortened postpartum stays may mean that mothers leave the hospital before the establishment of full milk production, without adequate opportunity for clinical observation or teaching of effective breastfeeding techniques, and without having learned the early signs of breastfeeding failure (4,8,9,11,12). These factors may contribute to the increased rates of rehospitalization due to feeding-related deficiencies such as malnutrition, dehydration, jaundice, and hypernatremia that have been reported in newborns who were discharged early (5,12–16). Several studies linked early discharge to mothers’ difficulties with breastfeeding (5,17,18), and to their concerns about breastfeeding competence and instruction (19,20). However, other research has found no relationship between breastfeeding and postpartum lengths of stay (20–24). Sheehan et al reported that premature cessation of breastfeeding was associated with postpartum hospitalizations longer than 48 hours (25). Thus, early discharge may mitigate the effects of hospital practices thought to inhibit breastfeeding, such as formula supplementation or the failure to provide rooming-in (11,17,25– 28). Several studies have associated positive breastfeeding outcomes with early discharge (27–30), but it is noteworthy that many of them included postdischarge care as part of the early discharge intervention (11,27). Much of the existing early discharge literature failed to include or directly measure breastfeeding outcomes (31–37), and most studies were restricted to full-term infants (21,24,27,29,33,34,38,39). Furthermore, the implications of variations in postdischarge care that may influence breastfeeding-related outcomes have not been adequately explored (14,20,21,33). Hence, to date, limited and contradictory evidence exists on the efficacy of postdischarge services in supporting successful breastfeeding among mother-infant pairs with shortened obstetrical stays. Several studies have found no impact on breastfeeding success when mothers were provided with in-home postpartum support (20,24,38,40,41). In other studies, home visits and other types of postdischarge support were significantly associated with a

greater and longer duration of breastfeeding (26,42– 44), or both. Postnatal home visits by health caregivers were also associated with high rates of maternal satisfaction (19,22,30,36,40,41,43,45). Our study was part of a larger one that compared the cost, safety, and efficacy of supporting breastfeeding in the hospital and home settings for term and near-term newborns. The purpose of this study was to compare the effects of routine hospital care and discharge with the effects of routine hospital care plus early discharge and home support on the breastfeeding success and maternal satisfaction of mothers of term and near-term infants. Methods After receiving approval from the Research Ethics Board of the host hospital, a randomized controlled trial with prognostic stratification for gestational age was undertaken in Toronto, Canada, from July 1999 to December 2000. Mothers were eligible if they had delivered a live, singleton infant within the preceding 12 hours, were at least 21 years of age, resided in the defined metropolitan area, had a telephone, intended to breastfeed, were breastfeeding at discharge, and would receive satisfactory support at home. Satisfactory support was determined by postpartum nurses who assessed mothers’ circumstances to ensure the safety and well-being of infants and mothers. The main criterion was that mothers were not isolated, and had accessible family and friends to provide assistance when necessary. Women were excluded if they did not speak English and had experienced cesarean deliveries, postpartum complications, and morbidities such as fever and abnormal bleeding, chronic illnesses, or disabilities. Their newborns were eligible to participate if they were 35 weeks’ gestational age or greater, were breastfed at discharge, and did not have congenital anomalies or morbidities, including hyperbilirubinemia, blood group incompatibility, or sepsis. Informed written consent was obtained from all mothers. Reflecting the obstetrical population that made use of this hospital, the participant pool tended to be white, middle-class socioeconomic status, and with some postsecondary education. Procedure The sample size estimation was based on the primary objective of the larger study, which was to detect economic differences in supporting lactation in the hospital and home settings. Since the actual distribution of costs was unknown, the sample size estimation was based on a multiple of the standard

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deviation. A sample of 40 home-based mother-infants pairs and 40 hospital-based mother-infant pairs would provide a power of 85 percent to detect a difference in cost equal to 0.67 standard deviations at the 0.05 level of significance using a two-tailed test. Using central randomization procedures, eligible mother-newborn pairs were stratified as term or near term (35–37 weeks’ gestational age), and allocated to either the standard or experimental groups by research staff who had no contact with patients. Mother-newborn pairs in the standard care group were cared for in the hospital and were discharged using standard hospital criteria at approximately 48 to 60 hours postpartum. Mother-newborn pairs in the experimental group were assessed at 24 to 36 hours postpartum and sent home if they met the same discharge criteria. Each mother-newborn pair in the experimental group was scheduled to receive up to 3 home visits from community nurses qualified as lactation consultants. Women were not evaluated until the end of the intervention, regardless of whether it consisted of 2 or 3 visits. Interviewers were originally blinded to group status. However, in the course of answering questions about postpartum care and satisfaction, mothers inadvertently revealed their group status. As a matter of standard hospital care, mothers of near-term infants in both groups were made aware of the outpatient hospital breastfeeding clinic, and were encouraged to use a preexisting 24-hour telephone help line. Mothers of term infants in both groups were also provided with information on these services. Data Collection Baseline measurements were obtained before randomization. Outcomes were assessed during a home visit scheduled at the mother’s convenience from 5 to 12 days postpartum. Breastfeeding rates were assessed by determining, first, the incidence and frequency of exclusive breastfeedings in the preceding 24 hours (defined as the mother feeding the newborn by breast, and excluding supplementation with expressed breastmilk or formula), and, second, the incidence and frequency of exclusive feeds of breastmilk in the preceding 24 hours (defined as the mother feeding the newborn by breast and/or by supplementing with expressed breastmilk, and excluding supplementation with formula). Adverse infant outcomes between the term standard care and experimental groups, such as hyperbilirubinemia, dehydration, or weight loss, were also determined. During the follow-up visit, mothers completed a brief semistructured, open-ended interview focusing on their perceptions of the benefits and limitations to breastfeeding support received in

Fig. 1. Trial profile for mothers of term infants. hospital and at home. Perceptions of care were elicited through a 70-item postpartum questionnaire (30) adapted by Dalby et al (46), in which mothers rated their satisfaction with postpartum care, and the types and frequency of assistance that they had used in the first 5 to12 days. Depending on mothers’ preferences, focused, open-ended interviews were audiotaped and transcribed (43 term, 20 near term), or transcribed by hand during the interviews (28 term, 4 near term). Given the structured nature of the interviews, qualitative data were categorized as the positive and negative aspects of receiving breastfeeding support in the hospital and home settings. Data were then grouped, coded and subjected to frequency counts. All quantitative data were double entered, logic checked, and corrected for errors. Two-sample t tests were used to compare normally distributed variables; nonparametric Wilcoxon rank sum tests were used to compare ordinal and skewed variables; and proportions were compared using the Fisher exact tests. Significance for all tests was set at 0.05, and all tests were two-tailed. Data were analyzed using the SAS statistical package (47). Results The findings for mothers of both term and near-term newborns in the experimental and standard care groups were analyzed independently, and will be discussed separately. Mothers of Term Newborns Of 156 eligible mothers of term newborns, 101 agreed to participate (Table 1) and were randomly assigned to the experimental (n ¼ 53) or standard care

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32.1 (4.4) 8 (80.0%) 2 (20.0%) 35 wk ¼ 5.6% 36 wk ¼ 33.3% 37 wk ¼ 61.1% 72% 95% CI (47%, 90%) 0.37 * p ¼