Using a Cohort-Based Quality Improvement Coaching Model to Optimize Chronic Disease Management for Federally Qualified Health Center Patients.

CONTEXT: In fall 2020, Community Clinic Association of Los Angeles County, in collaboration with the Los Angeles County Department of Public Health, launched a 3-year, cohort-based quality improvement (QI) coaching program to assist Federally Qualified Health Centers (FQHCs) in improving their clinical management of hypertension, high blood cholesterol, diabetes, and chronic kidney disease. PROGRAM: The QI program utilized a cohort-based coaching model in which 5 FQHCs were each assigned a practice transformation coach who provided them with guidance and support to monitor clinical quality measures. These measures were then used to facilitate changes and improvements in clinical workflows and approaches to patient care. To encourage peer learning and promote inter-organizational collaboration, the coaching team hosted quarterly cohort check-ins and an online group messaging board where the participating FQHCs could share lessons learned. Throughout the program, the FQHCs were provided trainings and resources to advance their clinical quality measures of choice. IMPLEMENTATION: To implement the program, each FQHC selected 2 clinical quality measures to focus on, completing a minimum of 1 Plan-Do-Study-Act cycle per year for each measure. Throughout, the coaches met regularly with FQHC staff to discuss progress, strategize on how best to address challenges encountered, and identify training or resource needs for their clinic sites. EVALUATION: To drive implementation of QI interventions and monitor overall progress, the FQHCs reported quarterly on the clinical quality measures being addressed. By program's end, all 5 FQHCs reached their 10% improvement goals. DISCUSSION: This QI coaching program allowed participating FQHCs to build new competencies and achieve measurable improvements in how they managed their patients' chronic diseases. This model of practice serves as a promising approach for achieving sustainable clinical improvements in these FQHCs.

Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates.

The continuous monitoring of arterial blood pressure (BP) is vital for assessing and treating cardiovascular instability in a sick infant. Currently, invasive catheters are inserted into an artery to monitor critically-ill infants. Catheterization requires skill, is time consuming, prone to complications, and often painful. Herein, we report on the feasibility and accuracy of a non-invasive, wearable device that is easy to place and operate and continuously monitors BP without the need for external calibration. The device uses capacitive sensors to acquire pulse waveform measurements from the wrist and/or foot of preterm and term infants. Systolic, diastolic, and mean arterial pressures are inferred from the recorded pulse waveform data using algorithms trained using artificial neural network (ANN) techniques. The sensor-derived, continuous, non-invasive BP data were compared with corresponding invasive arterial line (IAL) data from 81 infants with a wide variety of pathologies to conclude that inferred BP values meet FDA-level accuracy requirements for these critically ill, yet normotensive term and preterm infants.

Delivery of Comprehensive Medication Management and Other Clinical Services via Telehealth by Pharmacy Type.

BACKGROUND: The recent coronavirus pandemic accelerated the need to deliver pharmacy-related services remotely. OBJECTIVE: To describe experiences with providing comprehensive medication management (CMM) and other clinical services via telehealth by pharmacy type, before and during the COVID-19 pandemic. METHODS: An online survey of pharmacists, representing 27 pharmacies, was conducted to capture telehealth usage in three pharmacy types: independently owned, integrated into a clinical setting, and retail chain. A sub-analysis was performed to assess if providing CMM services via telehealth helped, resulted in no change, or worsened the care of different patient groups (e.g., those with diabetes, were low-income, aged 65+ years). RESULTS: During the pandemic, telehealth usage among independently owned pharmacies and those integrated into a clinical setting increased, but no change occurred among retail chain pharmacies. This usage increase in the first two pharmacy types occurred despite limited investments in connectivity-related resources to support telehealth services. Pharmacists from both independently owned pharmacies (63%) and those integrated into a clinical setting (89%) reported CMM via telehealth reached patients they would not otherwise have been able to reach during the pandemic. Most pharmacists/pharmacies found telehealth to be a feasible and acceptable method of delivering CMM. CONCLUSION: Pharmacists and pharmacies are now experienced with and have interest in continuing CMM via telehealth, even as the pandemic recedes. However, investments in telecommunications resources, training support, technical assistance, and continued telehealth reimbursement from health plans are needed to sustain this service delivery model.

Building bi-directional referral and communication pathways across the community-clinic divide: Experiences from a systems-informed innovation project in Los Angeles.

Bi-directional communication and referral pathways (BCRPs) between clinics and community-based organizations could promote well-being among vulnerable populations with complex and overlapping health and social needs. While BCRPs are promising, establishing them is complex, involving system and process changes across diverse organizational settings. To date, few models have been implemented or empirically tested. This article describes an innovation and planning project to build a BCRP, linking patients in safety net primary care clinics to a comprehensive suite of community-based health and wellness supports in Los Angeles. During a year-long process, a multi-sector team iteratively engaged data to facilitate learning and improvement. The project proceeded through three distinct, but overlapping, phases: (1) Discovery, (2) Systems Mapping, and (3) BCRP Re-design and Testing, which were coordinated through frequent collaborative meetings. By using a stepwise systems-informed approach to collect and examine data, the team was able to generate new change ideas, dispel assumptions, and make transparent and informed decisions. It was critical to have engagement from both internal partners with knowledge of "on-the-ground" practice realities, and external stakeholders with the fresh perspective needed to identify opportunities and define an improvement agenda. These efforts represent first steps towards implementing sustainable BCRPs and realizing their full potential to dynamically bridge the community-clinic divide and improve population health. Other jurisdictions can learn from and adapt the practical data-driven approach used in Los Angeles to build BCRPs that will be thoroughly operationalized, consistently implemented, and optimized within their own unique contexts.

Early life inflammation is associated with spinal cord excitability and nociceptive sensitivity in human infants.

Immune function and sensitivity to pain are closely related, but the association between early life inflammation and sensory nervous system development is poorly understood-especially in humans. Here, in term-born infants, we measure brain activity and reflex withdrawal activity (using EEG and EMG) and behavioural and physiological activity (using the PIPP-R score) to assess the impact of suspected early-onset neonatal infection on tactile- and noxious-evoked responses. We present evidence that neonatal inflammation (assessed by measuring C-reactive protein levels) is associated with increased spinal cord excitability and evoked brain activity following both tactile and noxious stimulation. There are early indications that this hyperalgesia could be maintained post-inflammation, supporting pre-clinical reports of early-life immune dysfunction influencing pain sensitivity in adults.

New method to measure interbreath intervals in infants for the assessment of apnoea and respiration.

BACKGROUND: Respiratory disorders, including apnoea, are common in preterm infants due to their immature respiratory control compared with term-born infants. However, our inability to accurately measure respiratory rate in hospitalised infants results in unreported episodes of apnoea and an incomplete picture of respiratory activity. METHODS: We develop, validate and use a novel algorithm to identify interbreath intervals (IBIs) and apnoeas in preterm infants. In 42 preterm infants (1600 hours of recordings), we assess IBIs from the chest electrical impedance pneumograph using an adaptive amplitude threshold for the detection of breaths. The algorithm is refined by comparing its accuracy with clinically observed breaths and pauses in breathing. We develop an automated classifier to differentiate periods of true apnoea from artefactually low amplitude signal. We assess the performance of this algorithm in the detection of morphine-induced respiratory depression. Finally, we use the algorithm to investigate whether retinopathy of prematurity (ROP) screening alters the IBI distribution. RESULTS: Individual breaths were detected with a false-positive rate of 13% and a false-negative rate of 12%. The classifier identified true apnoeas with an accuracy of 93%. As expected, morphine caused a significant shift in the IBI distribution towards longer IBIs. Following ROP screening, there was a significant increase in pauses in breathing that lasted more than 10 s (t-statistic=1.82, p=0.023). This was not reflected by changes in the monitor-derived respiratory rate and no episodes of apnoea were recorded in the medical records. CONCLUSIONS: We show that our algorithm offers an improved method for the identification of IBIs and apnoeas in preterm infants. Following ROP screening, increased respiratory instability can occur even in the absence of clinically significant apnoeas. Accurate assessment of infant respiratory activity is essential to inform clinical practice.

Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials.

Despite the high burden of pain experienced by hospitalised neonates, there are few analgesics with proven efficacy. Testing analgesics in neonates is experimentally and ethically challenging and minimising the number of neonates required to demonstrate efficacy is essential. EEG (electroencephalography)-derived measures of noxious-evoked brain activity can be used to assess analgesic efficacy; however, as variability exists in neonate's responses to painful procedures, large sample sizes are often required. Here, we present an experimental paradigm to account for individual differences in noxious-evoked baseline sensitivity which can be used to improve the design of analgesic trials in neonates. The paradigm is developed and tested across four observational studies using clinical, experimental, and simulated data (92 neonates). We provide evidence of the efficacy of gentle brushing and paracetamol, substantiating the need for randomised controlled trials of these interventions. This work provides an important step towards safe, cost-effective clinical trials of analgesics in neonates.

Hospitalized newborns often undergo medical procedures, like blood tests, without pain relief. This can cause the baby to experience short-term distress that may have negative consequences later in life. However, testing the effects of pain relief in newborns is challenging because, unlike adults, they cannot report how much pain they are experiencing. One way to overcome this is to record the brain activity of newborns during a painful procedure and to see how these signals are modified following pain relief. Randomized controlled trials are the gold standard for these kinds of medical assessments, but require a high number of participants to account for individual differences in how babies respond to pain. Finding ways to reduce the size of pain control studies could lead to faster development of pain relief methods. Here, Cobo, Hartley et al. demonstrate a way to reduce the number of newborns needed to test potential pain-relieving interventions. In the experiments, the brain activity of nine babies was measured after a gentle poke and after a painful clinically required procedure. Cobo, Hartley et al. found that the babies' response to the gentle poke correlated with their response to pain. Further data analysis revealed that this information can be used to predict the variability in pain experienced by different newborns, reducing the number of participants needed for pain relief trials. Next, Cobo, Hartley et al. used this new approach in two pilot tests. One showed that gently stroking an infant's leg before blood is drawn from their heel reduced their brains' response to pain. The second showed that giving a baby the painkiller paracetamol lessened the brain's response to immunisation. The new approach identified by Cobo, Hartley et al. may enable smaller studies that can more quickly identify ways to reduce pain in babies. Furthermore, this work suggests that gentle brushing and paracetamol could provide pain relief for newborns undergoing hospital acute procedures. However, more formal clinical trials are needed to test the effectiveness of these two strategies.

Addressing Challenges to Coordinating the Implementation of Place-Based Chronic Disease Prevention Interventions in Los Angeles.

CONTEXT: Chronic disease prevention initiatives have traditionally been structured to address a single disease, potentially limiting the scope of health impacts. In the past decade, initiatives have increasingly adopted a coordinated approach, in which multiple interventions are intended to work synergistically-often in a bounded geographic area-to address interrelated risk factors and diseases. However, despite increased interest in this coordinated approach, few examples exist of how coordination has been operationalized in local public health practice. IMPLEMENTATION: In 2014, the Los Angeles County Department of Public Health launched the 4-year Chronic Disease Prevention Strategy (CDPS). Through CDPS, the Los Angeles County Department of Public Health implemented a range of environmental, lifestyle change, and health system interventions intended to collectively reduce chronic disease among adults in Los Angeles, with concentrated implementation occurring in 1 high-need neighborhood. EVALUATION: This case study examined the activities undertaken to coordinate across CDPS interventions and documented challenges to these efforts. Data were collected via a document review of programmatic materials and structured conversations with staff leading implementation of CDPS interventions. RESULTS: Document review and structured conversations with staff identified 3 primary coordination activities: (1) collaborating on outreach materials to unify messaging, (2) developing a network of common partners, and (3) investing in shared data collection. Operational challenges identified were disparate short-term objectives across interventions, minimal alignment between clinical practice and CDPS goals, restrictions around bidirectional referrals between organizations, and limited bandwidth among new partners to engage with multiple CDPS interventions. Contextual challenges identified were competing social and political issues, and geographic fluidity regarding where community members sought health resources. CONCLUSION: Developing an initiative-specific coordination plan prior to implementation may help reduce challenges to coordination. Modifications in how health initiatives are funded and structured may be needed: greater flexibility in how funding is administered, and the inclusion of coordination-specific metrics, may enable more robust coordination.

Current practices, facilitators, and barriers experienced by program providers implementing the National Diabetes Prevention Program in Los Angeles County.

Individuals with prediabetes can lower their diabetes risk by participating in the National Diabetes Prevention Program (National DPP), an evidence-based, group lifestyle change program that is taught by a certified lifestyle coach. To date, studies have not explicitly compared National DPP implementation across multiple settings (i.e., types of organizations) to understand comparative setting advantages or challenges to engaging priority groups. The purpose of this study was to gain an in-depth understanding of: (a) the variation in National DPP implementation across clinic, community-based, and digital settings and (b) associated facilitators and barriers. The study focused on three core implementation domains: recruitment, retention, and data reporting. This study used a descriptive, qualitative approach to identify current practices, facilitators, and barriers to National DPP implementation by conducting semistructured key informant interviews in spring 2018 with 12 organizations delivering the National DPP in Los Angeles County. There was a general commonality between in-person settings (clinics and community-based), while the experiences of digital providers were relatively distinct. Recruitment and retention were widely described by all settings as labor- and time-intensive, while data reporting was seen as relatively less burdensome. All respondents reported using multiple recruitment strategies. Lifestyle coaches were seen as key to retention, and they spent substantial time engaging with participants outside of class, which often was not accounted for in program costs. Data reporting was easier for organizations that invested in sophisticated data management systems and had staff with sufficient data experience. This study advances knowledge around the translation of the National DPP in diverse settings in the nation's largest county and highlights opportunities for targeted, setting-specific support.

Non-contact physiological monitoring of preterm infants in the Neonatal Intensive Care Unit.

The implementation of video-based non-contact technologies to monitor the vital signs of preterm infants in the hospital presents several challenges, such as the detection of the presence or the absence of a patient in the video frame, robustness to changes in lighting conditions, automated identification of suitable time periods and regions of interest from which vital signs can be estimated. We carried out a clinical study to evaluate the accuracy and the proportion of time that heart rate and respiratory rate can be estimated from preterm infants using only a video camera in a clinical environment, without interfering with regular patient care. A total of 426.6 h of video and reference vital signs were recorded for 90 sessions from 30 preterm infants in the Neonatal Intensive Care Unit (NICU) of the John Radcliffe Hospital in Oxford. Each preterm infant was recorded under regular ambient light during daytime for up to four consecutive days. We developed multi-task deep learning algorithms to automatically segment skin areas and to estimate vital signs only when the infant was present in the field of view of the video camera and no clinical interventions were undertaken. We propose signal quality assessment algorithms for both heart rate and respiratory rate to discriminate between clinically acceptable and noisy signals. The mean absolute error between the reference and camera-derived heart rates was 2.3 beats/min for over 76% of the time for which the reference and camera data were valid. The mean absolute error between the reference and camera-derived respiratory rate was 3.5 breaths/min for over 82% of the time. Accurate estimates of heart rate and respiratory rate could be derived for at least 90% of the time, if gaps of up to 30 seconds with no estimates were allowed.

Residential Mobility Among Elementary School Students in Los Angeles County and Early School Experiences: Opportunities for Early Intervention to Prevent Absenteeism and Academic Failure.

School connectedness is closely linked to academic success: students who are engaged at school have better attendance and academic performance, and are less likely to drop out. Residential mobility - having moved homes - can increase the risk of a negative academic trajectory (e.g., absenteeism and academic failure). Increasing housing instability in the United States due to rising housing costs, especially in urban areas, has made residential mobility a growing concern. While existing research has examined residential mobility among students and its connection to long-term consequences such as absenteeism and academic failure, less is known about how residential mobility relates to potential intermediate school experiences (e.g., school disconnectedness, low perceived academic ability, and experiences with school violence and harassment) that contribute to a negative academic trajectory. This study examines associations between residential mobility in elementary school and school experiences in a large urban jurisdiction. Data were collected from a sample of public elementary school students in Los Angeles County (5th grade, n = 5,620) via the California Healthy Kids Survey (2013-2014). Descriptive, Chi-square, multiple logistic regression analyses, and predicted probabilities were performed to examine the relationships between past-year residential mobility and indicators of school connectedness and school-based relationships, perceived academic performance, and exposure to violence and harassment. More than a third (36.6%) of students in the analysis sample moved at least once in the past year. After adjusting for neighborhood and family factors, a higher number of past-year moves was significantly associated with poorer school experiences, including lower odds of school connectedness for high-movers (2+ moves) [adjusted odds ratio (AOR) = 0.77; 95% confidence interval (CI) = 0.68-0.86], compared to non-movers. Movers had lower odds of perceived academic ability (1 move: AOR = 0.72; CI = 0.63-0.83; 2+ moves: AOR = 0.55; CI = 0.44-0.69), but higher odds of exposure to violence and harassment as a victim (1 move: AOR = 1.26, CI = 1.17-1.37; 2+ moves: AOR = 1.34, CI = 1.17-1.54), and as a perpetrator (1 move: AOR = 1.21, CI = 1.08-1.36; 2+ moves: AOR = 1.54, CI = 1.24-1.92). These results highlight the value of developing and implementing strategies that can identify and support students who move at young ages, to prevent student disengagement and promote attendance and academic success early in their life trajectory.

Assessment of Signal Processing Methods for Measuring the Respiratory Rate in the Neonatal Intensive Care Unit.

Knowledge of the pathological instabilities in the breathing pattern can provide valuable insights into the cardiorespiratory status of the critically-ill infant as well as their maturation level. This paper is concerned with the measurement of respiratory rate in premature infants. We compare the rates estimated from the chest impedance pneumogram, the ECG-derived respiratory rhythms, and the PPG-derived respiratory rhythms against those measured in the reference standard of breath detection provided by attending clinical staff during 165 manual breath counts. We demonstrate that accurate RR estimates can be produced from all sources for RR in the 40-80 bpm (breaths per min) range. We also conclude that the use of indirect methods based on the ECG or the PPG poses a fundamental challenge in this population due to their poor behavior at fast breathing rates (upward of 80 bpm).

Birth experience in newborn infants is associated with changes in nociceptive sensitivity.

Vaginal birth prepares the fetus for postnatal life. It confers respiratory, cardiovascular and homeostatic advantages to the newborn infant compared with elective cesarean section, and is reported to provide neonatal analgesia. We hypothesize that infants born by vaginal delivery will show lower noxious-evoked brain activity a few hours after birth compared to those born by elective cesarean section. In the first few hours of neonatal life, we record electrophysiological measures of noxious-evoked brain activity following the application of a mildly noxious experimental stimulus in 41 infants born by either vaginal delivery or by elective cesarean section. We demonstrate that noxious-evoked brain activity is related to the mode of delivery and significantly lower in infants born by vaginal delivery compared with those born by elective cesarean section. Furthermore, we found that the magnitude of noxious-evoked brain activity is inversely correlated with fetal copeptin production, a surrogate marker of vasopressin, and dependent on the experience of birth-related distress. This suggests that nociceptive sensitivity in the first few hours of postnatal life is influenced by birth experience and endogenous hormonal production.

Understanding the Density and Distribution of Restaurants in Los Angeles County to Inform Local Public Health Practice.

INTRODUCTION: To describe the potential reach of restaurant-based strategies that seek to improve the healthfulness of menu options, it is important to understand the local restaurant environment, including the extent to which restaurants subject to policy mandates are located in communities disproportionately affected by diet-related diseases. METHODS: This cross-sectional study examined the restaurant environment in Los Angeles County, a large jurisdiction with diverse geographic and socioeconomic characteristics, specifically 1) the number and characteristics of restaurants; 2) the association between neighborhood sociodemographics and restaurant density; and 3) the association between neighborhood sociodemographics and restaurant characteristics, including chain status (large chain, small chain, independent restaurant). Data sources were 1) industry data on restaurant location and characteristics (N = 24,292 restaurants) and 2) US Census data on neighborhood sociodemographics (N = 247 neighborhoods). We conducted descriptive and bivariate analyses at the restaurant and neighborhood level. RESULTS: Countywide, only 26.5% of all restaurants were part of a large chain (a chain with ≥20 locations). We found positive associations between restaurant density and neighborhood proportions of non-Hispanic white residents and residents with more than a high school education. We found limited support to suggest a greater density of large chains in neighborhoods with lower socioeconomic status. CONCLUSION: Results highlight the potentially limited reach of strategies targeting chain restaurants and point to the importance of including small chain restaurants and independent restaurants in public health efforts to improve the healthfulness of restaurants. Understanding where restaurants are in relation to priority populations is a critical step to planning strategies that address diet-related disparities.

Behavioural discrimination of noxious stimuli in infants is dependent on brain maturation.

Changes in facial expression are an essential form of social communication and in nonverbal infants are often used to alert care providers to pain-related distress. However, studies of early human brain development suggest that premature infants aged less than 34 weeks' gestation do not display discriminative brain activity patterns to equally salient noxious and innocuous events. Here we examine the development of facial expression in 105 infants, aged between 28 and 42 weeks' gestation. We show that the presence of facial expression change after noxious and innocuous stimulation is age-dependent and that discriminative facial expressions emerge from approximately 33 weeks' gestation. In a subset of 49 infants, we also recorded EEG brain activity and demonstrated that the temporal emergence of facial discrimination mirrors the developmental profile of the brain's ability to generate discriminative responses. Furthermore, within individual infants, the ability to display discriminative facial expressions is significantly related to brain response maturity. These data demonstrate that the emergence of behavioural discrimination in early human life corresponds to our brain's ability to discriminate noxious and innocuous events and raises fundamental questions as to how best to interpret infant behaviours when measuring and treating pain in premature infants.

Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.

BACKGROUND: Infant pain has immediate and long-term effects but is undertreated because of a paucity of evidence-based analgesics. Although morphine is often used to sedate ventilated infants, its analgesic efficacy is unclear. We aimed to establish whether oral morphine could provide effective and safe analgesia in non-ventilated premature infants for acute procedural pain. METHODS: In this single-centre masked trial, 31 infants at the John Radcliffe Hospital, Oxford, UK, were randomly allocated using a web-based facility with a minimisation algorithm to either 100 µg/kg oral morphine sulphate or placebo 1 h before a clinically required heel lance and retinopathy of prematurity screening examination, on the same occasion. Eligible infants were born prematurely at less than 32 weeks' gestation or with a birthweight lower than 1501 g and had a gestational age of 34-42 weeks at the time of the study. The co-primary outcome measures were the Premature Infant Pain Profile-Revised (PIPP-R) score after retinopathy of prematurity screening and the magnitude of noxious-evoked brain activity after heel lancing. Secondary outcome measures assessed physiological stability and safety. This trial is registered with the European Clinical Trials Database (number 2014-003237-25). FINDINGS: Between Oct 30, 2016, and Nov 17, 2017, 15 infants were randomly allocated to morphine and 16 to placebo; one infant assigned placebo was withdrawn from the study before monitoring began. The predefined stopping boundary was crossed, and trial recruitment stopped because of profound respiratory adverse effects of morphine without suggestion of analgesic efficacy. None of the co-primary outcome measures differed significantly between groups. PIPP-R score after retinopathy of prematurity screening was mean 11·1 (SD 3·2) with morphine and 10·5 (3·4) with placebo (mean difference 0·5, 95% CI -2·0 to 3·0; p=0·66). Noxious-evoked brain activity after heel lancing was median 0·99 (IQR 0·40-1·56) with morphine and 0·75 (0·33-1·22) with placebo (median difference 0·25, 95% CI -0·16 to 0·80; p=0·25). INTERPRETATION: Administration of oral morphine (100 µg/kg) to non-ventilated premature infants has the potential for harm without analgesic efficacy. We do not recommend oral morphine for retinopathy of prematurity screening and strongly advise caution if considering its use for other acute painful procedures in non-ventilated premature infants. FUNDING: Wellcome Trust and National Institute for Health Research.

Nociceptive brain activity as a measure of analgesic efficacy in infants.

Pain in infants is undertreated and poorly understood, representing a major clinical problem. In part, this is due to our inability to objectively measure pain in nonverbal populations. We present and validate an electroencephalography-based measure of infant nociceptive brain activity that is evoked by acute noxious stimulation and is sensitive to analgesic modulation. This measure should be valuable both for mechanistic investigations and for testing analgesic efficacy in the infant population.

A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.

Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 µg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet.

Continuous non-contact vital sign monitoring in neonatal intensive care unit.

Current technologies to allow continuous monitoring of vital signs in pre-term infants in the hospital require adhesive electrodes or sensors to be in direct contact with the patient. These can cause stress, pain, and also damage the fragile skin of the infants. It has been established previously that the colour and volume changes in superficial blood vessels during the cardiac cycle can be measured using a digital video camera and ambient light, making it possible to obtain estimates of heart rate or breathing rate. Most of the papers in the literature on non-contact vital sign monitoring report results on adult healthy human volunteers in controlled environments for short periods of time. The authors' current clinical study involves the continuous monitoring of pre-term infants, for at least four consecutive days each, in the high-dependency care area of the Neonatal Intensive Care Unit (NICU) at the John Radcliffe Hospital in Oxford. The authors have further developed their video-based, non-contact monitoring methods to obtain continuous estimates of heart rate, respiratory rate and oxygen saturation for infants nursed in incubators. In this Letter, it is shown that continuous estimates of these three parameters can be computed with an accuracy which is clinically useful. During stable sections with minimal infant motion, the mean absolute error between the camera-derived estimates of heart rate and the reference value derived from the ECG is similar to the mean absolute error between the ECG-derived value and the heart rate value from a pulse oximeter. Continuous non-contact vital sign monitoring in the NICU using ambient light is feasible, and the authors have shown that clinically important events such as a bradycardia accompanied by a major desaturation can be identified with their algorithms for processing the video signal.