A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials.

Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.

Difference between body composition of formula- and breastfed infants at birth.

Breastfeeding may reduce obesity risk, but this association could be confounded by breastfeeding families' characteristics. We investigated if body composition differs at birth among infants who were either exclusively breast- or formula-fed. We hypothesized the two groups would differ in body composition, even at birth, prior to their post-natal feeding experience. Healthy primiparous carrying singleton pregnancy were recruited at 15 weeks' gestation. PEA POD® measured body composition within 72 hours of delivery and infant feeding was prospectively captured. Out of the 1,152 infants recruited, 117 (10.2%) and 239 (20.7%) went on to be either exclusively breast- or formula-fed, respectively. Breastfed infants were heavier at birth, but their percentage fat mass (FM) was lower than that of exclusively formula-fed infants (covariate adjusted ß = -1.91 percentage points of FM; 95% CI -2.82 to -1.01). Differences in intra-uterine exposures, irrespective of early diet, may partly explain an infant's obesity risk.

Infant formula feeding practices in a prospective population based study.

BACKGROUND: It is recommended that formula-fed infants are given standard whey-based infant formula throughout the first year of life, unless otherwise advised by healthcare professionals. To our knowledge it has not yet been explored if parents are using a whey-based infant formula throughout the first 12 months of life. Reasons for parental choice of formula are also unknown. Therefore, the objective of this paper was to describe parental administration of whey-based and non whey-based infant formula in the first year of life. METHODS: Data collected as part of the Cork BASELINE Birth Cohort Study examined infant feeding practices at 2, 6 and 12 months of age. Descriptive analysis explored infant feeding practices and parental reasons for changing from a whey-based to a non whey-based infant formula. Multiple logistic regression investigated parental and infant characteristics associated with the use of whey-based infant formula. RESULTS: In total, 62.4%, 40.4% and 12.8% parent(s) at 2, 6 and 12 months, respectively, gave their infant whey-based infant formula. No parental or infant characteristic was found to consistently influence the use of whey-based infant formula. The most common reason reported by parent(s) for changing their infant's formula to a non whey-based formula was that they perceived their baby as being hungry. CONCLUSION: The majority of parent(s) commence their infants on whey-based formula, but most change to non whey-based formula before 12 months of age. Parental perception of infant satiety and not healthcare advice was the most common reason for changing from a whey-based to a non whey-based infant formula. Additional research is now required to investigate the effect of whey-based and non whey-based infant formula on infant growth.

Early life factors associated with the exclusivity and duration of breast feeding in an Irish birth cohort study.

OBJECTIVE: to investigate the influence of parental and infant characteristics on exclusive breast feeding from birth to six months of age and breast feeding rates at two, six and 12 months of age in Ireland. METHODOLOGY: secondary data analysis from the Cork BASELINE Birth Cohort Study (http://www.baselinestudy.net/). Infants were seen at birth and two, six, and 12 months of age. Maternal and paternal history, neonatal course and feeding data were collected at birth and using parental questionnaires at each time point. PARTICIPANTS: 1094 singleton infants of primiparous women recruited at 20 weeks' gestation who were breastfeeding on discharge from the maternity hospital. FINDINGS: at discharge from the maternity hospital and at two months, neonatal intensive-care unit admission had the strongest influence on exclusive breast feeding status (adjusted OR 0.17, 95% CI 0.07-0.41 at discharge) and at two months (adjusted OR=0.20, 95% CI 0.05-0.83). A shorter duration of breast feeding was significantly associated with younger maternal age, non-tertiary education, Irish nationality and neonatal intensive-care unit admission. There was a significant difference in the duration of any breast feeding between infants who were and were not admitted to the neonatal intensive-care unit, 28(10.50, 32) weeks versus 32(27, 40) weeks. Mothers whose maternity leave was between seven and 12 months (adjusted OR=2.76, 95% CI 1.51-5.05) breast fed for a longer duration compared to mothers who had less than six months of maternity leave. KEY CONCLUSIONS: admission to the neonatal intensive care unit negatively influenced both exclusivity and duration of breast feeding. Length of maternity leave, and not employment status, was significantly associated with duration of breast feeding. IMPLICATIONS FOR PRACTICE: additional support may be required to ensure continued breast feeding in infants admitted to the neonatal intensive-care unit. Length of maternity leave is a modifiable influence on breast feeding and offers the opportunity for intervention to improve our rates of breast feeding.