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

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.

SUBMITTER: Ericson J

PROVIDER: S-EPMC3654949 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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

Ericson Jenny J Eriksson Mats M Hellström-Westas Lena L Hagberg Lars L Hoddinott Pat P Flacking Renée R

BMC pediatrics 20130510

<h4>Background</h4>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 m ...[more]

PMID: 23663521

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Project description:Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective.This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline.The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation.

Project description:INTRODUCTION:Many women cease breastfeeding earlier than desired. This study examined the cessation of breastfeeding among mothers of preterm infants. Thus, the aim was to describe the cessation of breastfeeding in mothers of preterm infants up to 12 months after birth. METHOD:This mixed methods study used a convergent design with both qualitative data, consisting of written comments, and quantitative data, on breastfeeding status and breastfeeding satisfaction. The data were collected from questionnaires sent to the mothers at three points during the first year after birth. In total, 270 mothers of preterm infants who breastfed at the time of discharge from the neonatal unit provided data for the study. The quantitative and qualitative data were analysed separately with statistical tests and hermeneutical analysis, respectively and then together according to the convergent mixed methods design. RESULTS:Four themes of the meanings of the cessation of breastfeeding were identified in the qualitative analysis: "Desire to regain the mother's and the infant's well-being", "The mothers interpretation that the infants actively ceased breastfeeding", "The mother's body and/or the infants' signals showing the way" and "The mother's own will and perceived external obstacles". Mothers who did not breastfeed as long as they wanted were more likely to report less satisfaction with breastfeeding, a shorter breastfeeding period, and less activity when ceasing breastfeeding. In comparison, mothers who breastfed as long as they wanted were more satisfied with breastfeeding, breastfed for a longer period of time and were more active in decision making in breastfeeding cessation. CONCLUSION:Maternal passivity or activity influenced the cessation of breastfeeding in mothers of preterm infants who breastfed at the time of discharge from the neonatal unit. Passive behaviour related to breastfeeding may result in early cessation of breastfeeding, and low breastfeeding satisfaction while active behaviour may increase breastfeeding length and satisfaction.

Project description:ObjectiveTo assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.DesignRandomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen living in disadvantaged areas initiating breast feeding.MethodsEligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.Main outcome measuresPrimary outcomeany breast feeding at 6-8 weeks assessed by a telephone call from a researcher blind to group allocation.Secondary outcomesexclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.ResultsThere was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6-8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6-8 weeks; costs were sensitive to service organisation.ConclusionsProactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.Trial registration numberISRCTN27207603. The study protocol and final report are available on request.

Project description:ObjectiveThe Ringing Up about Breastfeeding earlY (RUBY) randomised controlled trial (RCT) of proactive telephone-based peer support for breastfeeding found that infants of women allocated to the intervention were more likely to be receiving breast milk at 6 months of age than those receiving usual care. This study explores women's experiences of receiving the RUBY peer support intervention.DesignCross-sectional survey.SettingWomen were recruited from the postnatal units of three tertiary hospitals in Melbourne, Australia.ParticipantsWomen allocated to receive telephone peer support in the RUBY RCT who completed a telephone interview at 6 months postpartum (501/574 (87%) in trial intervention arm) were invited to complete a postal survey on their experience of receiving support.OutcomesExperiences of support from the allocated peer, perceived helpfulness, topics discussed, overall satisfaction with the support and frequency and duration of contact were explored.ResultsSurveys were sent between August 2013 and March 2016, and 72% (360/501) responded of whom 341 recalled receiving peer support. Women reported high levels of perceived helpfulness (79%) and overall satisfaction with the peer support (93%). Discussions included breastfeeding topics (milk supply, attachment), baby care, baby behaviour, and reassurance and emotional support. Women valued the practical and realistic support from another mother, as well as the proactive nature, continuity and accessibility of the support. The empathy, reassurance and encouragement provided helped the mothers to 'cope', to continue breast feeding and to feel empowered.ConclusionMost respondents were positive about their experience of receiving proactive telephone peer support for breastfeeding, further supporting the roll-out of this model as a strategy for increasing breastfeeding maintenance to 6 months. Recommendations include flexibility in the scheduling of calls according to individual need, and the use of text messages in conjunction with proactive calls, to enhance and facilitate communication between the peer and the mother.Trial registration numberACTRN12612001024831.

Project description:ObjectiveTo assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.DesignParticipatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen initiating breast feeding and living in disadvantaged areas.MethodsQuantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.Main outcome measuresQuantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.ResultsA median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff-team-woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.ConclusionsImplementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.Trial registrationISRCTN27207603. The study protocol and final report is available on request.

Project description:BackgroundMothers of preterm infants face many challenges in breastfeeding, especially regarding lactation. This study aimed to investigate the lactation status and challenges in breastfeeding faced by preterm infants' mothers.MethodsWe approached 124 mothers who gave birth to preterm infants between 26 May and 31 October 2018 in a tertiary hospital in China. Lactation status and challenges in breastfeeding on day 7 postpartum, at discharge of infants, 2 weeks post-discharge, and 3 months of corrected age were collected using questionnaires. The area under the receiver operating characteristic (ROC) curve for expressed milk volume on day 7 postpartum for predicting expressed milk volume ≥ 300 mL/d at discharge was calculated. Logistic regression analyses were performed to identify factors associated with delayed lactogenesis II onset and continuation of breastfeeding at 3 months of corrected age.ResultsSeventy mothers were enrolled, and 51.4% had delayed lactogenesis II. Multivariate logistic regression analysis revealed that older maternal age (aOR = 1.19; 95% CI: 1.01, 1.40) and first live birth (aOR = 4.81; 95% CI 1.43, 16.18) were significant independent predictors of delayed lactogenesis II. Mothers with delayed lactogenesis II had significantly lower expressed milk volume (day 7 postpartum: 160.0 mL vs. 300.0 mL, U = 328.50, p = 0.001; at discharge: 425.0 mL vs. 612.5 mL, U = 372.00, p = 0.005), with a lower proportion of exclusive breastfeeding in their infants (at discharge: 33.3% vs. 69.8%, χ2 = 12.39, df = 1, p < 0.001; 3 months of corrected age: 17.8% vs. 52.8%, χ2 = 11.03, df = 1, p = 0.001). The ROC showed that expressed milk volume > 190 mL/d on day 7 postpartum significantly predicted expressed milk volume ≥ 300 mL/d at discharge. Insufficient human milk was the main reason for breastfeeding discontinuation at 3 months of corrected age. Twins were less likely to continue breastfeeding at 3 months of corrected age (aOR = 0.27; 95% CI 0.09, 0.86). In singleton infants, mother's own milk ≥50% of total milk uptake at 2 weeks post-discharge (aOR = 32.66; 95% CI 3.00, 355.25) was an independent predictor of continuous breastfeeding at 3 months of corrected age. Feeding complications in infants, poor breastfeeding technique, and low milk output are the main challenges in breastfeeding.ConclusionInterventions to improve early postpartum lactation and breastfeeding techniques may increase breastfeeding adoption in mothers of preterm infants.

Dataset Information

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

Publications

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

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