Exclusively breastmilk-fed preterm infants are at high risk of developing subclinical vitamin K deficiency despite intramuscular prophylaxis at birth.

BACKGROUND: There is near-global consensus that all newborns be given parenteral vitamin K1 (VK1 ) at birth as prophylaxis against VK deficiency bleeding (VKDB). Breastmilk has a low VK content and cases of late VKDB are reported in exclusively breastmilk-fed preterm infants despite VK prophylaxis at birth. OBJECTIVES: To assess the prevalence of functional VK insufficiency in preterm infants based on elevated under-γ-carboxylated (Glu) species of Gla proteins, factor II (PIVKA-II), and osteocalcin (GluOC), synthesized by liver and bone, respectively. PATIENTS/METHODS: Prospective, multicenter, observational study in preterm infants born <33 weeks' gestation. Blood samples and dietary history were collected before hospital discharge, and after discharge at 2-3 months' corrected age. Outcome measures were serum VK1 , PIVKA-II, and %GluOC (GluOC as a percentage of the sum of GluOC plus GlaOC) compared between exclusively breastmilk-fed and formula/mixed-fed infants after discharge. RESULTS: After discharge, breastmilk-fed babies had significantly lower serum VK1 (0.15 vs. 1.81 µg/L), higher PIVKA-II (0.10 vs. 0.02 AU/ml) and higher %GluOC (63.6% vs. 8.1%) than those receiving a formula/mixed-feed diet. Pre-discharge (based on elevated PIVKA-II), only one (2%) of 45 breastmilk-fed infants was VK insufficient. After discharge, eight (67%) of 12 exclusively breastmilk-fed babies were VK insufficient versus only one (4%) of 25 formula/mixed-fed babies. CONCLUSIONS: Preterm infants who remain exclusively or predominantly human breastmilk-fed after neonatal unit discharge are at high risk of developing subclinical VK deficiency in early infancy. Routine postdischarge VK1 supplementation of breastfed infants to provide intakes comparable to those from formula milks should prevent this deficiency.

Mixed methods evaluation of a hospital group model using an embedded research approach: study protocol.

INTRODUCTION: Hospital group models represent an organisational form that aims to bring together multiple provider organisations with a central headquarters and unified leadership responsible for locally managed operating units, standardised systems and a value-set shared across the group. These models seek to improve outcomes by reducing unwarranted variations in care provision and reducing costs through economies of scale. There is limited evidence on the impact and processes of implementing these models, so this study aims to evaluate one case study of a hospital group model. METHODS AND ANALYSIS: We will conduct a formative, mixed-methods evaluation using an embedded research approach to analyse the implementation of the model and its impact on outcomes and costs. We will carry out a multisited ethnography to analyse the programme theory for model design and implementation, the barriers and facilitators in the implementation; and wider contextual issues that influence implementation using semi-structured interviews (n=80), non-participant observations (n=80 hours), 'shadowing' (n=20 hours) and documentary analysis. We will also carry out an economic evaluation composed of a cost-consequence analysis and a return on investment analysis to evaluate the costs of creating and running the model and balance these against the potential cost-savings. ETHICS AND DISSEMINATION: The study protocol was reviewed by the local R&D Office and University College London Ethics Committee and classified as a service evaluation, not requiring approval by a research ethics committee. We will follow guidelines for informed consent, confidentiality and information governance, and address issues of critical distance prevalent in embedded research. Findings will be shared at regular time points to inform the implementation of the model. The evaluation will also generate: an evaluation framework to evaluate future changes; recommendations for meaningful baseline data and measuring improvement; identification of implementation costs and potential cost-savings; and lessons for the National Health Service on implementing these models.

The relationship of locus of control, self-control, and acceptable noise levels for young listeners with normal hearing.

OBJECTIVE: Background noise acceptance while listening to speech, assessed via the acceptable noise level (ANL) measure, has been shown to be an accurate predictor of hearing-aid success. No specific listener characteristics have been identified as being related to a listener's ability to accept background noise. The purpose of this study was to determine whether or not locus of control and self-control are related to ANL. DESIGN: Correlational design. STUDY SAMPLE: Participants were seventy young adults (21 male, 49 female; aged 19 to 39 years) with normal hearing. Participants completed psychological profiles that evaluated locus of control and self-control and their ANLs were measured. RESULTS: Results revealed correlations between ANL and self-control. Listeners with higher levels of self-control accepted more background noise than listeners with lower levels of self-control. CONCLUSIONS: This research suggests that exercises aimed at strengthening a listener's auditory self-control may lead to improved background noise acceptance. Improvement in background noise acceptance could lead to improved hearing-aid success. Future research should explore these possibilities.