Carol Bedwell

Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial

BackgroundSome national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of a specifically formulated cleansing wipe on the napkin area of newborn infants (<1 month) has an equivalent effect on skin hydration when compared with using cotton wool and water (usual care).MethodsA prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010. Healthy, term babies (n = 280), recruited within 48 hours of birth, were randomly assigned to have their napkin area cleansed with an alcohol-free baby wipe (140 babies) or cotton wool and water (140 babies). Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks.ResultsComplete hydration data were obtained for 254 (90.7 %) babies. Wipes were shown to be equivalent to water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5 (14.2), p = 0.47, 95 % CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6 (14.3), p = 0.53, 95 % CI -2.4 to 4.2). No significant differences were found in the secondary outcomes, except for maternal-reported napkin dermatitis, which was higher in the water group (p = 0.025 for complete responses).ConclusionsBaby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use baby wipes and to health professionals who support their use.Trial registrationCurrent Controlled Trials ISRCTN86207019

Randomized, Controlled Trial Evaluating a Baby Wash Product on Skin Barrier Function in Healthy, Term Neonates

Objectives To examine the hypothesis that the use of a wash product formulated for newborn (<1 month of age) bathing is not inferior (no worse) to bathing with water only. Design Assessor-blinded, randomized, controlled, noninferiority trial. Setting A teaching hospital in the Northwest of England and in participants’ homes. Participants Three-hundred-and-seven healthy, term infants recruited within 48 hours of birth. Method We compared bathing with a wash product (n = 159) to bathing with water alone (n = 148). The primary outcome was transepidermal water loss (TEWL) at 14 days postbirth; the predefined difference deemed to be unimportant was 1.2. Secondary outcomes comprised changes in stratum corneum hydration, skin surface pH, clinical observations of the skin, and maternal views. Results Complete TEWL data were obtained for 242 (78.8%) infants. Wash was noninferior to water alone in terms of TEWL (intention-to-treat analysis: 95% confidence interval [CI] for difference [wash–water, adjusted for family history of eczema, neonate state, and baseline] −1.24, 1.07; per protocol analysis: 95% CI −1.42, 1.09). No significant differences were found in secondary outcomes. Conclusion We were unable to detect any differences between the newborn wash product and water. These findings provide reassurance to parents who choose to use the test newborn wash product or other technically equivalent cleansers and provide the evidence for health care professionals to support parental choice.

The use of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour: a review of the evidence

OBJECTIVE to assess the effects of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. SEARCH METHODS studies were identified from a search of the Cochrane Pregnancy and Childbirth Groups Trials Register (November 2008). SELECTION CRITERIA randomised controlled trials comparing women receiving TENS for pain relief in labour vs routine care or placebo devices. All types of TENS machines were included. DATA COLLECTION AND ANALYSIS two review authors assessed all trials identified by the search strategy, carried out data extraction and assessed risk of bias. RESULTS 14 studies including 1256 women were included: 11 examined TENS applied to the back, two to acupuncture points and one to the cranium. Overall, there was little difference in satisfaction with pain relief or in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32-0.55). The majority of women using TENS would use it again in a future labour. There was no evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and infants. No adverse events were reported. CONCLUSIONS there is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact on other outcomes for mothers or infants. The use of TENS at home in early labour has not been evaluated. Although the guidelines of the National Institute for Health and Clinical Excellence recommend that TENS should not be offered to women in labour, women appear to be choosing it and midwives are supporting them in their choice. Given the absence of adverse effects and the limited evidence base, it seems unreasonable to deny women that choice. More robust studies of effectiveness are needed.

Using diaries to explore midwives' experiences in intrapartum care: An evaluation of the method in a phenomenological study

AIM finding appropriate ways of obtaining contemporaneous data in acute settings is an ethical and practical dilemma for researchers. Our aim was to evaluate the use of diaries by midwives in a research study informed by a phenomenological approach. SETTING AND SAMPLE a purposive sample of 12 midwives working across three Trusts in the North West of England. METHOD a phenomenological approach was used to guide a study exploring midwives views of confidence when providing intrapartum care. Two methods of data collection were used; diaries and semi-structured interviews. This is a methodological paper reporting on the usefulness of diaries used with participants who were health professionals in a health-care setting. RESULTS participants completing qualitative diaries provided rich data, recording not only a description of events but also their emotional response to such events. A high degree of self-reflection and analysis was also evident. The participants provided contextual and time situated data although remaining focused on the phenomena being explored. Furthermore, the diaries highlighted the data that may not have been uncovered by interview alone. CONCLUSION use of diaries for qualitative data collection is feasible and well received by health professionals. Individuals completing diaries were engaged in a reflective process enabling them to address significant events. Hence, diaries may provide benefits to both the researcher and the participant. They proved appropriate to a study requiring an exploration of the lived experience of the participants. Researchers conducting research informed by a phenomenological perspective should consider diaries as a valuable data collection tool.

The Challenges and Realties of Diaper Area Cleansing for Parents

OBJECTIVE To explore the complexities of diaper area cleansing reported by women participating in a randomized controlled trial designed to compare optimally formulated baby wipes (Johnsons Baby Skincare fragrance free wipe) with cotton wool and water. DESIGN A mixed-method design incorporating quantitative and qualitative methods to explore maternal views and experiences of using baby wipes or cotton wool and water to cleanse their newborns diaper area over an 8-week period. SETTING Participants were recruited from a large regional maternity hospital in Northern England. PARTICIPANTS Participants included 280 women and their healthy term newborns; 252 provided 4-week data (90.0%) and 237 provided 8-week data (85.0%). METHODS Data from diaries and structured face-to-face interviews at 4 weeks and telephone interviews at 8 weeks were transcribed and thematically analyzed to identify themes. Quantitative data were compared between randomized groups using descriptive statistics and two-group tests, where appropriate. RESULTS Major themes identified highlighted the practical realities of diaper area cleansing, diaper area cleansing and everyday life, and living with the rhetoric that water is best. Baby wipes were perceived as more convenient efficient at cleansing. Some women using cotton wool and water did not cleanse skin after urination alone. Diaper changing was significantly more frequent in the baby wipes group at 4 weeks, but there was no significant difference between the groups at 8 weeks. CONCLUSION Women are faced with a complex environment regarding diaper area cleansing and need clear evidence-based advice and guidance on effective diaper area cleansing.

'She can choose, as long as I'm happy with it': a qualitative study of expectant fathers' views of birth place.

OBJECTIVES A programme of research was undertaken to explore which factors contributed to decisions regarding birth place. As part of this programme, the views of male partners of pregnant women were examined to gain understanding of their contribution to the decision making process, with regard to different birth settings. STUDY DESIGN A qualitative interpretive approach was utilised to explore, in-depth, the views of 19 expectant fathers, in the North West of England. Semi-structured interviews were conducted, audio recorded and transcribed, following consent. Data were analysed using a thematic approach. FINDINGS Four main themes were identified; Silent decisions, Powers of persuasion, Trust in a medical environment and Personal vulnerability. CONCLUSIONS Choice regarding place of birth is multi-dimensional. Expectant fathers are likely to contribute to their partners decision making; their motivation can relate to their own beliefs and personal vulnerability as well the need to protect the women. The overwhelming trust in the medical environment dominates partners views regarding birth place. The lack of discussion regarding birth place, between partners and with health professionals, reinforces the notion that hospital birth is safest, thus strengthening the normalization of birth in this environment. Midwives need to engage with expectant fathers to ensure that their contributions to decisions around birth place are fully informed.

A realist review of the partograph: when and how does it work for labour monitoring?

BackgroundThe partograph (or partogram) is recommended by the World Health Organisation (WHO), for monitoring labour wellbeing and progress. Concerns about limitations in the way the partograph is used in the clinical context and the potential impact on its effectiveness have led to this realist systematic review of partograph use.MethodsThis review aimed to answer two key questions, 1) What is it about the partograph that works (or does not work); for whom does it work; and in what circumstances? 2) What are the essential inputs required for the partograph to work? A comprehensive search strategy encompassed key databases; including papers of varying methodologies. Papers were selected for inclusion if the focus of the paper was the partograph and related to context, mechanism or outcome. Ninety five papers were included for data synthesis. Two authors completed data extraction and synthesis.ResultsThe evidence synthesis relates the evidence to identified theories of health worker acceptability, health system support, effective referral systems, human resources and health worker competence, highlighting barriers and facilitators.ConclusionsThis first comprehensive realist synthesis of the partograph, provides the international community of maternity clinicians with a picture of potential issues and solutions related to successful labour recording and management, which is also translatable to other monitoring approaches.

The interpretation and effect of a low-carbohydrate diet in the management of type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials

Background/objectivesRecently, the role of a low-carbohydrate diet in diabetes management has generated interest with claims being made regarding its superiority over the traditional high-carbohydrate, low-fat dietary approach. This systematic review and meta-analysis evaluated the interpretation and effect of a low-carbohydrate diet in the management of type 2 diabetes.Subjects/methodsRandomised controlled trials were searched for which included adults with type 2 diabetes aged 18 years or more. The intervention was a low-carbohydrate diet as defined by the author compared to a control group of usual care. MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, ISRCTN, ProQuest and opengrey.eu were searched. Independent experts were contacted and reference lists of selected papers were checked. Results were analysed descriptively and meta-analyses were completed to include trials that presented data at 1 year.ResultsEighteen studies (n = 2204) were eligible for inclusion within the systematic review. The definition of a low-carbohydrate diet varied. At trial end, the descriptive analysis suggested that the low-carbohydrate intervention arm (LCIA) may promote favourable outcomes in terms of HbA1c, triglycerides and HDL cholesterol. The LCIA demonstrated reduced requirements for diabetes medication, which may have reduced the observed benefit of dietary carbohydrate restriction on HbA1c. Seven studies provided data to be included in the meta-analyses at 1 year. The meta-analyses showed statistical significance in favour of the LCIA for HbA1c (estimated effect = −0.28%, 95% CI −0.53 to −0.02, p = 0.03; χ2 = 13.15, df = 6, p = 0.03; I2 = 54%), HDL cholesterol (estimated effect = 0.06 mmol/L, 95% CI 0.04–0.09, p < 0.00001; χ2 = 6.05, df = 6, p = 0.42; I2 = 1%), triglycerides (estimated effect = −0.24 mmol/L, 95% CI −0.35 to −0.13, p < 0.0001; χ2 = 1.88, df = 6, p = 0.93; I2 = 0%) and systolic blood pressure (estimated effect = −2.74 mmHg, 95% CI −5.27 to −0.20, p = 0.03; χ2 = 10.54, df = 6, p = 0.10; I2 = 43%). Meta-analyses for weight, total cholesterol, LDL cholesterol and diastolic blood pressure did not demonstrate a statistically significant difference between interventions.Dietary adherence was an issue in most studies. A very low-carbohydrate diet (<50 g/day) seems unrealistic in this population, however, a low-carbohydrate diet (<130 g/day) appears to be achievable. Improved clinical outcomes were observed in some studies as a result of achieving a low- or moderate-carbohydrate diet.Fifteen out of 18 studies were considered high risk of bias, with performance bias being a common issue.ConclusionsReducing dietary carbohydrate may produce clinical improvements in the management of type 2 diabetes. Further research is needed to understand the true effect of dietary carbohydrate restriction on HbA1c independent of medication reduction and to address known issues with adherence to this dietary intervention. Clarity is needed regarding appropriate classification of a low-carbohydrate diet.

Skin care for healthy babies at term: a systematic review of the evidence

OBJECTIVES to identify what skin practices are important for the protection of baby skin in healthy term babies (0-6 months) and generate evidence-based conclusions to inform health professionals and parents. DESIGN eleven databases were searched for all empirical quantitative and qualitative research published between 2000-2015 which explored baby skin care for bathing and cleansing, nappy care, hair and scalp care, management of dry skin or baby massage, for healthy term babies up to 6 months old. Papers not published in English were excluded. A total of 3062 papers were identified. Pairs of reviewers assessed all citations and extracted data independently. There were 26 included papers: 16 RCTs, 3 non-randomised experimental studies, 1 mixed-methods study and 6 qualitative studies. Primary and secondary outcome measures were analysed using meta-analysis or narrative descriptive statistics. Synthesis of qualitative data was not possible due to disparity of the evidence. FINDINGS from the small numbers of studies with comparable data, there was no evidence of any significant differences between tested wash products and water or tested baby wipes and water. There was some evidence to suggest that daily use of full-body emollient therapy may help to reduce the risk of atopic eczema in high risk babies with a genetic predisposition to eczema; however, the use of olive oil or sunflower oil for baby dry skin may adversely affect skin barrier function. There was no evidence about hair/scalp care or baby massage. Qualitative research indicates that parents and health professionals believe that water alone is best. KEY CONCLUSIONS meta-analysis was restricted due to the lack of consistency of study outcome measures. Although there is considerable RCT evidence comparing the use of specific products against water alone, or another product, for bathing, cleansing and nappy care, the power of this evidence is reduced due to inconsistency of outcome measures in terms of outcome, treatment site or time-point. The development of a core outcome measure set is advocated for trials assessing skin care practices. IMPLICATIONS FOR PRACTICE this review offers health professionals best evidence available on which to base their advice. Of those studies with comparative outcomes, the evidence indicates no difference between the specific products tested and water alone; offering parents a choice in their baby skin care regimen. Protocol available: http://www.crd.york.ac.uk/PROSPEROFILES/28054_PROTOCOL_20151009.pdf.