Support for healthy breastfeeding mothers with healthy term babies.

BACKGROUND: There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant's diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation. OBJECTIVES: 1. To describe types of breastfeeding support for healthy breastfeeding mothers with healthy term babies. 2. To examine the effectiveness of different types of breastfeeding support interventions in terms of whether they offered only breastfeeding support or breastfeeding support in combination with a wider maternal and child health intervention ('breastfeeding plus' support).  3. To examine the effectiveness of the following intervention characteristics on breastfeeding support:      a. type of support (e.g. face-to-face, telephone, digital technologies, group or individual support, proactive or reactive);      b. intensity of support (i.e. number of postnatal contacts);      c. person delivering the intervention (e.g. healthcare professional, lay person);     d. to examine whether the impact of support varied between high- and low-and middle-income countries. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes results of searches of CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP)) (11 May 2021) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Support could be provided face-to-face, over the phone or via digital technologies. All studies had to meet the trustworthiness criteria.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed risk of bias and study trustworthiness.  The certainty of the evidence was assessed using the GRADE approach. MAIN RESULTS: This updated review includes 116 trials of which 103 contribute data to the analyses. In total more than 98,816 mother-infant pairs were included.  Moderate-certainty evidence indicated that 'breastfeeding only' support probably reduced the number of women stopping breastfeeding for all primary outcomes: stopping any breastfeeding at six months (Risk Ratio (RR) 0.93, 95% Confidence Interval (CI) 0.89 to 0.97); stopping exclusive breastfeeding at six months (RR 0.90, 95% CI 0.88 to 0.93); stopping any breastfeeding at 4-6 weeks (RR 0.88, 95% CI 0.79 to 0.97); and stopping exclusive breastfeeding at 4-6 (RR 0.83 95% CI 0.76 to 0.90). Similar findings were reported for the secondary breastfeeding outcomes except for any breastfeeding at two months and 12 months when the evidence was uncertain if 'breastfeeding only' support helped reduce the number of women stopping breastfeeding.  The evidence for 'breastfeeding plus' was less consistent. For primary outcomes there was some evidence that 'breastfeeding plus' support probably reduced the number of women stopping any breastfeeding (RR 0.94, 95% CI 0.91 to 0.97, moderate-certainty evidence) or exclusive breastfeeding at six months (RR 0.79, 95% CI 0.70 to 0.90).  'Breastfeeding plus' interventions may have a beneficial effect on reducing the number of women stopping exclusive breastfeeding at 4-6 weeks, but the evidence is very uncertain (RR 0.73, 95% CI 0.57 to 0.95). The evidence suggests that 'breastfeeding plus' support probably results in little to no difference in the number of women stopping any breastfeeding at 4-6 weeks (RR 0.94, 95% CI 0.82 to 1.08, moderate-certainty evidence). For the secondary outcomes, it was uncertain if 'breastfeeding plus' support helped reduce the number of women stopping any or exclusive breastfeeding at any time points.  There were no consistent findings emerging from the narrative synthesis of the non-breastfeeding outcomes (maternal satisfaction with care, maternal satisfaction with feeding method, infant morbidity, and maternal mental health), except for a possible reduction of diarrhoea in intervention infants.  We considered the overall risk of bias of trials included in the review was mixed. Blinding of participants and personnel is not feasible in such interventions and as studies utilised self-report breastfeeding data, there is also a risk of bias in outcome assessment.   We conducted meta-regression to explore substantial heterogeneity for the primary outcomes using the following categories: person providing care; mode of delivery; intensity of support; and income status of country.  It is possible that moderate levels (defined as 4-8 visits) of 'breastfeeding only' support may be associated with a more beneficial effect on exclusive breastfeeding at 4-6 weeks and six months. 'Breastfeeding only' support may also be more effective in reducing women in low- and middle-income countries (LMICs) stopping exclusive breastfeeding at six months compared to women in high-income countries (HICs). However, no other differential effects were found and thus heterogeneity remains largely unexplained. The meta-regression suggested that there were no differential effects regarding person providing support or mode of delivery, however, power was limited.  AUTHORS' CONCLUSIONS: When 'breastfeeding only' support is offered to women, the duration and in particular, the exclusivity of breastfeeding is likely to be increased. Support may also be more effective in reducing the number of women stopping breastfeeding at three to four months compared to later time points.  For 'breastfeeding plus' interventions the evidence is less certain. Support may be offered either by professional or lay/peer supporters, or a combination of both. Support can also be offered face-to-face, via telephone or digital technologies, or a combination and may be more effective when delivered on a schedule of four to eight visits. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

Cue-based versus scheduled feeding for preterm infants transitioning from tube to oral feeding: the Cubs mixed-methods feasibility study.

BACKGROUND: There is a lack of evidence of the effect of cue-based feeding compared with scheduled feeding on important outcomes for preterm infants. OBJECTIVES: The objectives were as follows: (1) to describe the characteristics, components, theoretical basis and outcomes of approaches to feeding preterm infants transitioning from tube to oral feeding; (2) to identify operational policies, barriers and facilitators, and staff and parents' educational needs in neonatal units implementing cue-based feeding; (3) to co-produce an intervention for feeding preterm infants in response to feeding cues; (4) to appraise the willingness of parents and staff to implement and sustain the intervention; (5) to assess associated costs of implementing cue-based feeding; (6) to determine the feasibility and acceptability of a future trial; (7) to scope existing data-recording systems and potential outcome measures; and (8) to determine stakeholders' views of whether or not a randomised controlled trial of this approach is feasible. DESIGN: This was a mixed-methods intervention development and feasibility study comprising (1) a systematic review, case studies, qualitative research and stakeholder consensus; (2) the co-production of the intervention; (3) a mixed-methods feasibility study; and (4) an assessment of stakeholder preferences for a future evaluation. SETTING: Three neonatal units in the UK (two level 3 units and one level 2 unit). PARTICIPANTS: Developmentally normal, clinically stable preterm infants receiving enteral feeds (n = 50), parents (n = 15 pre intervention development; n = 14 in the feasibility study) and health-care practitioners (n = 54 pre intervention development; n = 16 in the feasibility study). INTERVENTION: An evidence-informed multicomponent intervention comprising training, a feeding protocol, feeding assessment tools, supplementary training materials [including posters, a film and a narrated PowerPoint (Microsoft Corporation, Redmond, WA, USA) presentation] and the 'Our Feeding Journey' document. MAIN OUTCOME MEASURES: The main outcome measures were recruitment and screening rates, infant weight gain, duration of the intervention, feeding outcomes, implementation outcomes (contextual facilitators and barriers, acceptability, adoption, appropriateness and fidelity) and stakeholder preferences for a future evaluation. RESULTS: The systematic review of 25 studies concluded that evidence in favour of cue-based feeding should be treated cautiously. The case studies and qualitative research highlighted contextual barriers to and facilitators of the implementation of cue-based feeding. The telephone survey found that many neonatal units are considering implementing cue-based feeding. We recruited 37% of eligible infants, and there was good retention in the study until discharge but a high loss to follow-up at 2 weeks post discharge. The mean number of days from intervention to transition to full oral feeding was 10.8, and the mean daily change in weight gain was 25 g. The intervention was acceptable to parents and staff, although there was dissatisfaction with the study documentation. Intervention training did not reach all staff. A cluster-randomised design with a composite outcome was suggested by stakeholders for a future study. LIMITATIONS: The intervention was available only in English. Intervention training did not reach all staff. There was low recruitment to qualitative interviews and observations. Only a small number of medical staff engaged in either the training or the interviews. CONCLUSIONS: It is feasible to implement a cue-based feeding intervention with improved training and documentation. Further work is needed to assess the feasibility of a future trial, noting evidence of existing lack of equipoise. FUTURE WORK: The next steps are to digitalise the intervention and conduct a survey of all neonatal units in the UK. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018097317 and ISRCTN13414304. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 74. See the NIHR Journals Library website for further project information.

Preterm babies who are ready to progress from tube feeding to oral feeding are usually fed according to a fixed schedule. Scheduled feeding protocols set a minimum corrected gestational age at which oral feeding may commence, and specify the rate of change from tube to oral feeding. Scheduled feeding also sets the volume and timing of each feed. A few small studies show that feeding babies according to their cues might have benefits for them and their parents; for example, babies may be discharged from hospital sooner. Cue-based feeding may help parents to understand the needs of their baby and be more involved in their care. Examples of hunger cues are mouthing movements, bringing hands to mouth and sucking. Examples of stop cues are falling asleep and stopping sucking. We developed a cue-based feeding intervention and tested it in three neonatal units to see if a large trial could be done and if parents and staff liked the intervention. We reviewed previous research, visited three hospitals that use cue-based feeding and interviewed parents and staff about their experiences of feeding preterm babies. We developed the intervention with parents and staff. The intervention included a feeding protocol, training for parents and staff, and a feeding record. Parents and staff liked most parts of the intervention. The training did not reach all staff, and staff and parents found it time-consuming to record every feed. Many parents and staff thought that cue-based feeding was better for babies, and parents thought that neonatal units should change to cue-based feeding. We discussed our findings with parents, staff and research experts. Based on their ideas, we recommend that the intervention is developed into an app (application) and that all neonatal units in the UK are surveyed to find out if they use cue-based feeding and if they would agree to be part of a large trial.

Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial.

BACKGROUND: Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed 'hard-to-reach' in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. METHODS: THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. RESULTS: THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. CONCLUSIONS: Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number Registry ISRCTN21656568 . Retrospectively registered on 28 February 2014.

Qualitative evaluation of an innovative midwifery continuity scheme: Lessons from using a quality care framework.

INTRODUCTION: Innovative midwifery schemes must be robustly evaluated to establish whether they should be modified or can be replicated. Assessing quality of care can help to ascertain a scheme's acceptability and effectiveness. We used an established quality care framework as a benchmark in our qualitative evaluation of a combined continuity of caregiver and planned home birth scheme in Scotland. METHODS: Qualitative evaluation of stakeholder perceptions using the Quality Maternal and Newborn Care Framework was the basis for six focus groups and two one-to-one interviews with stakeholders (new mothers, partners, midwives). A thematic analytical approach was used. RESULTS: The qualitative evaluation found universal approval among participants. Flexible working patterns helped to nurture positive relationships, and information and support were highly valued. The principal themes-Organization of Care/Work Culture; Information and Support; Relationships-were strongly inter-related. They shared several subthemes, notably continuity of caregiver, flexible family-centered care, and the benefits of being at home. Flexibility and mutual respect helped women to express autonomy and develop agency. Women related their birth experiences to friends, family, and colleagues, thereby helping to normalize home birth. CONCLUSIONS: This qualitative evaluation of an innovative scheme used an established quality framework as a benchmark against which to assess stakeholder experiences. This approach helped to identify the critical codependence of factors involved in care delivery, which in turn helps to identify lessons for others considering similar schemes. Although our evaluation relates to one specific scheme, identifying the scheme's critical quality care aspects may assist others when planning similar schemes.

Process lessons from evaluating a combined continuity of carer and home birth scheme.

INTRODUCTION: Continuity of midwifery carer improves outcomes, but there is significant variation in how such schemes are implemented and evaluated cross-culturally. The Angus home birth scheme in Scotland incorporates continuity of carer throughout pregnancy, labor, birth, and the postnatal period. METHODS: Manual maternity case note review to evaluate the 80% continuity of carer and 3% planned home birth rate targets. RESULTS: Of 1466 women booking for maternity care, 69 joined the scheme. Forty-four had a planned home birth (3% overall), of whom seven were originally deemed ineligible. Of the 44, eight (18%) also achieved 80% continuity of carer with the primary midwife; by including a home birth team colleague, the continuity rate rose to 73%. Women whose care achieved home birth and continuity targets had lower deprivation scores. Eligibility issues, women's changing circumstances, and data recording lapses were complicating issues. CONCLUSIONS: Targets must be both feasible and meaningful and should be complemented by assessing a broad range of outcomes while viewing the scheme holistically. By expanding eligibility criteria, the home birth rate target was met; including input from a home birth team colleague in the calculation meant the continuity target was nearly met. With dedicated and competent staff, adequate resource and political support, and when considered in the round, the scheme's viability within local services was confirmed. Other generalizable learning points included the need to standardize definitions and data recording methods. Comparability across schemes helps grow the evidence base so that the links between processes and outcomes can be identified.

Systematic review of barriers to, and facilitators of, the provision of high-quality midwifery services in India.

BACKGROUND: The Indian government has committed to implementing high-quality midwifery care to achieve universal health coverage and reduce the burden of maternal and perinatal mortality and morbidity. There are multiple challenges, including introducing a new cadre of midwives educated to international standards and integrating midwifery into the health system with a defined scope of practice. The objective of this review was to examine the facilitators and barriers to providing high-quality midwifery care in India. METHODS: We searched 15 databases for studies relevant to the provision of midwifery care in India. The findings were mapped to two global quality frameworks to identify barriers and facilitators to providing high-quality midwifery care in India. RESULTS: Thirty-two studies were included. Key barriers were lack of competence of maternity care providers, lack of legislation recognizing midwives as autonomous professionals and limited scope of practice, social and economic barriers to women accessing services, and lack of basic health system infrastructure. Facilitators included providing more hands-on experience during training, monitoring and supervision of staff, utilizing midwives to their full scope of practice with good referral systems, improving women's experiences of maternity care, and improving health system infrastructure. CONCLUSIONS: The findings can be used to inform policy and practice. Overcoming the identified barriers will be critical to achieving the Government of India's plans to reduce maternal and neonatal mortality through the introduction of a new cadre of midwives. This is unlikely to be effective until the facilitators described are in place.