"A roller coaster of emotions": a qualitative study of parents very first experiences with their preterm baby

Objectives: To assess parents 19 first experiences of their very preterm babies and the neonatal intensive care unit (NICU). Design: Qualitative study using semistructured interviews. Participants: 32 mothers and 7 fathers of very preterm babies (<32 weeks gestation). Setting: Three neonatal units in tertiary care hospitals in South East England. Results: Five themes were identified. The first describes parents 19 blurred recall of the birth. The second shows the anticipation of seeing and touching their baby for the first time was characterised by contrasting emotions, with some parents feeling scared and others excited about the event. The third theme describes parents 19 first sight and touch of their babies and their 18rollercoaster 19 of emotions during this time. It also highlights the importance of touch to trigger and strengthen the parent 13baby bond. However, some parents were worried that touching or holding the baby might transmit infection or interfere with care. The fourth theme captures parents 19 impressions of NICU and how overwhelming this was particularly for parents who had not toured NICU beforehand or whose first sight of their baby was on NICU. The final theme captures unique experiences of fathers, in particular that many felt excluded and confused about their role. Conclusions: This study informs family-centred care by providing insight into the experiences of parents of very preterm infants at a time when they are most in need of support. Clinical implications include the importance of offering parents preparatory tours of the NICU and including fathers

Dietary fat and corticosterone levels are contributing factors to meal anticipation

Daily restricted access to food leads to the development of food anticipatory activity and metabolism, which depends upon an as yet unidentified food-entrainable oscillator(s). A premeal anticipatory peak in circulating hormones, including corticosterone is also elicited by daily restricted feeding. High-fat feeding is associated with elevated levels of corticosterone with disrupted circadian rhythms and a failure to develop robust meal anticipation. It is not clear whether the disrupted corticosterone rhythm, resulting from high-fat feeding contributes to attenuated meal anticipation in high-fat fed rats. Our aim was to better characterize meal anticipation in rats fed a low- or high-fat diet, and to better understand the role of corticosterone in this process. To this end, we utilized behavioral observations, hypothalamic c-Fos expression, and indirect calorimetry to assess meal entrainment. We also used the glucocorticoid receptor antagonist, RU486, to dissect out the role of corticosterone in meal anticipation in rats given daily access to a meal with different fat content. Restricted access to a low-fat diet led to robust meal anticipation, as well as entrainment of hypothalamic c-Fos expression, metabolism, and circulating corticosterone. These measures were significantly attenuated in response to a high-fat diet, and animals on this diet exhibited a postanticipatory rise in corticosterone. Interestingly, antagonism of glucocorticoid activity using RU486 attenuated meal anticipation in low-fat fed rats, but promoted meal anticipation in high-fat-fed rats. These findings suggest an important role for corticosterone in the regulation of meal anticipation in a manner dependent upon dietary fat content

Parents' experiences and satisfaction with care during the birth of their very preterm baby: a qualitative study

Objective: To assess parents' experiences and satisfaction with care during very preterm birth and to identify domains associated with positive and negative experiences of care. Design: Qualitative study using semi-structured interviews. Setting: Three neonatal units in tertiary care hospitals in South-East England. Population: Thirty-two mothers and seven fathers who had a baby born before 32 weeks of gestation and spoke English well. Methods: Semi-structured interviews were conducted. Results were analysed using thematic analysis. Main outcome measures Participants' experiences and satisfaction with care during the birth of their preterm baby. Results: Overall, 80% of participants were extremely satisfied with the care during the birth of their preterm baby, seven were generally satisfied but felt some things could be improved and one was dissatisfied. Four key determinants of experiences of care were identified: staff professionalism, which included information and explanation, being calm in a crisis, appearing confident and in control, and conversely not listening to the woman; staff empathy, which included caring and emotional support, and encouragement and reassurance; involvement of the father; and birth environment. Conclusions: Although the determinants of experiences of care are generally consistent with previous research on term births, unique factors to preterm birth were identified. These were the importance of the staff appearing calm during the birth, and the staff portraying confidence and taking control during the birth. Women valued being listened to, and both they and their partners valued staff helping fathers to feel involved during the birth

Self-Hypnosis for Intrapartum Pain management (SHIP) in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness

Abstract Objective: (Primary): to establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use Design: Multi-method RCT Setting: Three NHS Trusts Population: Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. Methods: Randomisation at 28-32 weeks gestation to usual care, or to usual care plus brief self-hypnosis training (two x 90 minute groups at around 32 and 35 weeks gestation; daily audio self-hypnosis CD). Follow up at two and six weeks postnatal. Main outcome measures:- Primary: epidural analgesia Secondary: associated clinical and psychological outcomes; economic analysis. Results: 680 women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 (95% confidence interval (CI): 0.64 to 1.24), or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and two weeks post natal (anxiety: OR -0.72, 95% CI -1.16 to -0.28, P= 0.001); fear (OR -0.62, 95% CI -1.08 to -0.16, p = 0.009) Postnatal response rates were 67% overall at two weeks. The additional cost of the intervention per woman was £4.83 (CI -£257.93 to £267.59). Conclusions: Allocation to two third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women’s anxiety and fear about childbirth needs further investigation. Trial registration: ISRCTN27575146 http://www.controlled-trials.com/ISRCTN2757514

Measuring parents’ experiences and satisfaction with care during very preterm birth: a questionnaire development study

Objective: To develop a questionnaire to assess parents’ experiences and satisfaction with care during very preterm birth. Design: Questionnaire development. Setting: Parents whose babies had been cared for at five tertiary neonatal units in England. Population: A total of 145 women who gave birth before 32 weeksof gestation, and 85 of their partners. Methods: A 30-item questionnaire was developed on the basis of qualitative interviews with parents of very preterm babies, a literature review and discussion with relevant experts. The questionnaire was posted to a second group of parents, and its reliability and validity were explored. Main outcome measures The Preterm Birth Experience and Satisfaction Scale (P-BESS) was correlated with two global questions measuring satisfaction with care during the birth. Internal consistency was measured using Cronbach’s a. Results: Parents of 458 babies were invited to take part and 147 (32%) responded. Two women and 22 partners were excluded or ineligible, leaving 145 women and 85 partners. Factor analysis produced three clear dimensions: Staff professionalism and empathy, Information and explanations, and Confidence in staff. The total scale and three subscales showed high reliability. Strong positive correlations were found between the questionnaire scales and the two global questions, indicating convergent validity. For women whose partners were present at the birth, a fourth factor was identified ‘Partner Involvement’. Conclusions: The P-BESS appears to be a valid measure of satisfaction with care during very preterm birth

Evaluation of expressive writing for postpartum health: A randomized controlled trial

Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect the health of women. There is some evidence that expressive writing can have positive effects on psychological and physical health, particularly during stressful periods. The current study aimed to evaluate whether expressive writing would improve women’s postpartum health. A randomized controlled trial was conducted with three conditions: expressive writing (n=188), a control writing task (n=213), or normal care (n=163). Measures of psychological health, physical health and quality of life were measured at baseline (6-12 weeks postpartum), 1 month and 6 months later. Ratings of stress were taken before and after the expressive writing task. Intent-to-treat analyses showed no significant differences between women in the expressive writing, control writing and normal care groups on measures of physical health, anxiety, depression, mood or quality of life at 1 and 6 months. Uptake and adherence to the writing tasks was low. However, women in the expressive writing group rated their stress as significantly reduced after completing the task. Cost analysis suggest women who did expressive writing had the lowest costs in terms of healthcare service use and lowest cost per unit of improvement in quality of life. Results suggest expressive writing is not effective as a universal intervention for all women 6-12 weeks postpartum. Future research should examine expressive writing as a targeted intervention for women in high-risk groups, such as those with mild or moderate depression, and further examine cost-effectiveness

Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness

Objective: (Primary) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use. Design: Multi-method randomised control trial (RCT). Setting: Three NHS Trusts. Population: Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. Methods: Randomisation at 28–32 weeks’ gestation to usual care, or to usual care plus brief self-hypnosis training (two × 90-minute groups at around 32 and 35 weeks’ gestation; daily audio self-hypnosis CD). Follow up at 2 and 6 weeks postnatal. Main outcome measures: Primary: epidural analgesia. Secondary: associated clinical and psychological outcomes; cost analysis. Results: Six hundred and eighty women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 [95% confidence interval (CI): 0.64–1.24], or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal (anxiety: mean difference −0.72, 95% CI −1.16 to −0.28, P = 0.001); fear (mean difference −0.62, 95% CI −1.08 to −0.16, P = 0.009) [Correction added on 7 July 2015, after first online publication: ‘Mean difference’ replaced ‘Odds ratio (OR)’ in the preceding sentence.]. Postnatal response rates were 67% overall at 2 weeks. The additional cost in the intervention arm per woman was £4.83 (CI −£257.93 to £267.59). Conclusions: Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women's anxiety and fear about childbirth needs further investigation

Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial

Background: Preterm birth is the most important single determinant of adverse outcome in the United Kingdom; one in every 70 babies (1.4%) is born before 32 weeks (very preterm), yet these births account for over half of infant deaths. Deferring cord clamping allows blood flow between baby and placenta to continue for a short time. This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation. Optimal timing for clamping the cord remains uncertain, however. The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome, but larger studies reporting substantive outcomes and with long-term follow-up are needed. Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes. This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK. Methods/Design: Women are eligible for the trial if they are expected to have a live birth before 32 weeks gestation. Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome, triplet or higher order multiple pregnancy, and known major congenital malformation. The interventions will be cord clamping within 20 seconds compared with cord clamping after at least two minutes. For births with cord clamping after at least two minutes, initial neonatal care is at the bedside. For the pilot trial, outcomes include measures of recruitment, compliance with the intervention, retention of participants and data quality for the clinical outcomes. Information about the trial is available to women during their antenatal care. Women considered likely to have a very preterm birth are approached for informed consent. Randomisation is close to the time of birth. Follow-up for the women is for one year, and for the children to two years of age (corrected for gestation at birth). The target sample size is 100 to 110 mother-infant pairs recruited over 12 months at eight sites. Trial registration: ISRCTN21456601, registered on 28 February 2013

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project

BACKGROUND: The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multinational, clinical trials in Europe. METHODS: Participants in the ECRAN consortium included clinicians and methodologists directly involved in clinical trials; researchers working in partnership with the public and patients; representatives of patients; and experts in science communication. We searched for, and evaluated, relevant existing materials and developed additional materials and tools, making them freely available under a Creative Commons licence. RESULTS: The principal communication materials developed were: 1. A website ( http://ecranproject.eu ) in six languages, including a Media centre section to help journalists to disseminate information about the ECRAN project 2. An animated film about clinical trials, dubbed in the 23 official languages of the European Community, and an interactive tutorial 3. An inventory of resources, available in 23 languages, searchable by topic, author, and media type 4. Two educational games for young people, developed in six languages 5. Testing Treatments interactive in a dozen languages, including five official European Community languages 6. An interactive tutorial slide presentation testing viewers' knowledge about clinical trials CONCLUSIONS: Over a 2-year project, our multidisciplinary and multinational consortium was able to produce, and make freely available in many languages, new materials to promote public knowledge about the importance of independent and international clinical trials. Sustained funding for the ECRAN information platform could help to promote successful recruitment to independent clinical trials supported through the European Clinical Research Infrastructure Network