Martin L. Lee

Background: Very low birth weight (VLBW, <1500 g) infants are at increased risk for necrotizing enterocolitis (NEC) and other morbidities. An exclusive human milk diet (EHMD) may reduce complications compared with bovine fortifier or formula, but its clinical and economic benefits remain debated. Aim: To evaluate the impact of EHMD implementation on clinical outcomes and healthcare resource utilization in VLBW infants at a single center. Methods: This retrospective cohort study included VLBW infants admitted to El Paso Children's Hospital from February 2012 to September 2019. The pre-EHMD group (2012–2014, n = 104) received preterm formula or bovine fortifier, while the EHMD group (2014–2019, n = 225) received mother's or donor human milk with human milk-based fortifier until 34 weeks postmenstrual age. Outcomes included NEC, parenteral nutrition (PN) and antibiotic days, central line use, blood transfusions, growth, and healthcare costs. Summary: Despite lower gestational age and birth weight, the EHMD group had significantly lower rates of NEC (12.5% vs. 4.9%) and surgical NEC (8.7% vs. 3.1%), as well as fewer PN, antibiotic, and central line days and fewer blood transfusions. Periventricular leukomalacia was also reduced (26.9% vs. 19.6%), while growth outcomes were comparable. Although EHMD had higher upfront costs, overall resource savings yielded a favorable cost-benefit ratio of 1.83. These findings support EHMD as a clinically effective and economically advantageous strategy for VLBW infants.

An exclusive human milk diet (EHMD) and standardized feeding protocols are two critical methods for safely feeding very low birth weight (VLBW) infants. Our institution initiated a standardized feeding protocol for all VLBW infants in 2018. In this protocol, a human milk fat modular was used only reactively when an infant had poor weight gain, fluid restriction, or hypoglycemia. As part of our NICU quality improvement program, internal utilization review data revealed a potential opportunity to improve growth and reduce costs. While maintaining the EHMD, a simple feeding guideline process change could provide cost savings without sacrificing caloric density or growth. We examined this process change in pre-post cohorts of VLBW infants. Methods: Our revised feeding protocol, established in October 2021, called for a human milk fat modular (Prolact CR) to be added to all infant feeding when parenteral nutrition (PN) and lipids were discontinued. The human milk fat modular concentration is 4 mL per 100 mL feed, providing approximately an additional 2 kcal/oz. We tracked data to compare (1) the use of the human milk fat modular, (2) the use of the human milk +8 fortifier, (3) overall growth before and after feeding protocol changes, and (4) cost differences between protocols. Results: Thirty-six VLBW infants were followed prospectively upon the introduction of the revised feeding protocol. In the revised era, the need for human milk +8 fortifier decreased from 43% to 14%. The decrease in the cost of a more costly fortifier provided a cost savings of USD 2967.78 on average per infant. Overall growth improved from birth to discharge, with severe malnutrition declining from 3.3% to 2.7% and moderate malnutrition declining from 37% to 8%. Conclusions: With the proactive use of a human milk fat modular in a standardized feeding protocol, our VLBW infants showed improved growth, lower malnutrition rates, and decreased use of higher caloric fortifiers.

Preterm infants born at very low birth weight (VLBW) are at increased risk of developing many highly morbid conditions such as necrotizing enterocolitis (NEC), periventricular leukomalacia (PVL), and retinopathy of prematurity (ROP). This leads to a significant emotional and cost burden for their families and the healthcare system. Previous literature has established that an exclusive human milk diet (EHMD) when compared to a diet containing bovine milk is associated with decreased incidence of several of these life-threatening conditions. This single center retrospective review at a hospital on the US-Mexico Border compares outcomes of VLBW infants pre- and post- initiation of an EHMD. Infants following an EMHD feeding protocol began fortification on average three days earlier and had their first feeds earlier. The EHMD group had lower incidences of both surgical and medical necrotizing enterocolitis (NEC), and fewer total parenteral nutrition (TPN), central venous line (CVL), and antibiotic days and fever blood transfusions with comparable growth outcomes. In aggregate, this yielded a substantial cost savings.

Introduction: Previous studies have suggested that prescribed cannabidiol (CBD) products may cause elevations in liver tests (LT). This study compared the prevalence of elevated LT in an adult population self-administering CBD with the normal and general adult population prevalences. Materials and Methods: Adults 18–75 years of age across the United States taking CBD orally for a minimum of 30 days were recruited from 12 individual CBD product companies in this decentralized, observational study and sent their standard CBD regimen from the company of their choice. An app-based, 21CFR Part 11 decentralized clinical study platform (ValidCare Study) was used to securely automate consent inclusion/exclusion criteria and collect all the data for this study, including: demographic information, medical history, reasons for taking, dosage, current medications dosage, adverse effects, and efficacy. At the end of 30 days, LTs were obtained. Follow-up LTs were offered to all individuals with elevated alanine transaminase (ALT) values. Results: A total of 28,121 individuals were invited to participate in this study, 1475 enrolled, and 839 (female: 65.3%, male: 34.7%) completed the study. Full-spectrum hemp oil was used by 55.7%, CBD-isolate by 40.5%, and broad spectrum by 3.8%. The mean±SD daily dose of CBD was 50.3+40.7 mg. The prevalence of elevated ALT was 9.1%, aspartate aminotransferase (AST) 4.0%, alkaline phosphatase 1.9%, total bilirubin 1.7%, with 85.5% of the ALT elevations 3× ULN. The prevalence of ALT and AST elevations (9.1% and 4.0%) were not significantly different from known adult general population prevalences (8.9% and 4.9%). There was no significant association between CBD dosage and LT values. Thirty-three individuals with elevated ALT levels had follow-up LT performed with 21 having normal LT, 8 having the same severity of ALT elevation, and 4 having an increase in severity, 1 of which ultimately became normal. Conclusions: Self-medication of CBD does not appear to be associated with an increased prevalence of LT elevation and most of the LT elevations are likely due to the conditions/medications for which the individuals are taking CBD.

Background: Preterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust association between prematurity and increased cardiovascular risk factors and cardiovascular mortality. While the innate adverse effects of prematurity on these outcomes have been demonstrated, therapeutic strategies on the mitigation of these concerning developments are lacking. The primary objective of the NEOVASC clinical trial is therefore to investigate whether the administration of a prolonged exclusive human-milk diet in preterm infants is capable of alleviating the harmful effects of preterm birth on the early development of cardiovascular risk factors.Methods: The NEOVASC study is a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial conducted in four Austrian tertiary neonatal care facilities. The purpose of the present trial is to investigate the effects of a prolonged exclusive human-milk-diet devoid of bovine-milk-based food components on cardiovascular and metabolic risk factors at 1, 2, and 5 years of corrected age. Primary outcomes include assessments of fasting blood glucose levels, blood pressure levels, and the distensibility of the descending aorta using validated echocardiographic protocols at 5 years of corrected age. The test group, which consists of 200 preterm infants, will therefore be compared to a control group of 100 term-born infants and a historical control group recruited previously.Discussion: Given the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants’ nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing.Trial registration: ClinicalTrials.govNCT04413994. Registered on 4 June 2020.

Objective: Small for gestational age (SGA) preterm infants (PT) are at greatest risk for growth failure. Our objective was to assess the impact of an exclusive human milk diet (HUM) on growth velocities and neonatal morbidities from birth to discharge in a SGA population. Study design: Multicenter, retrospective cohort study, subgroup analysis of SGA PT comparing a cow’s milk diet (CMD) with HUM diet. Results: At birth 420 PT were classified as SGA (197 CMD group, 223 HUM group). Demographics and anthropometric measurements were similar. HUM group PT showed improvement in length Z score at discharge (p = 0.024) and reduction in necrotizing enterocolitis (NEC) (p = 0.004). Conclusion: SGA PT fed a HUM diet had significantly decreased incidence of NEC, surgical NEC, and late-onset sepsis. Due to concerns about growth in a HUM diet, it is reassuring SGA infants fed the HUM diet had similar growth to CMD diet with trends toward improvement.

Objective: To compare health care system problems or “hassles” experienced by Veterans receiving VA health care only versus those receiving dual care from both VA and non‐VA community providers.Data Sources: We collected survey data in 2017‐2018 from 2444 randomly selected Veterans with four or more primary care visits in the prior year at one of 12 VA primary care clinics located in four geographically diverse regions of the United States.Study Design: We used baseline surveys from the Coordination Toolkit and Coaching quality improvement project to explore Veterans’ experience of hassles (dependent variable), source of health care, self‐rated physical and mental health, and sociodemographics.Data Collection: Participants responded to mailed surveys by mail, telephone, or online.Principal Findings: The number of reported hassles ranged from 0 to 16; 79 percent of Veterans reported experiencing one or more hassles. Controlling for sociodemographic characteristics and self‐rated physical and mental health, zero‐inflated negative binominal regression indicated that dual care users experienced more hassles than VA‐only users (adjusted predicted average 5.5 [CI: 5.2, 5.8] vs 4.3 [CI: 4.1, 4.6] hassles [P < .0001]).Conclusions: Anticipated increases in Veterans accessing community‐based care may require new strategies to help VA primary care teams optimize care coordination for dual care users.

Parkinson’s disease, the second most common neurodegenerative disease, is diagnostically defined by motor impairments, but also includes often under-recognized impairments in cognition, mood, sleep, and the autonomic nervous system. These problems can severely affect individuals’ quality of life. In our prior research, we have developed indicators to measure the quality of care delivered to patients with Parkinson’s disease, and we identified gaps in delivering evidence-based treatments for this population. Effective strategies to close these gaps are needed to improve patient quality of life. Building on prior research we developed a multi-faceted proactive implementation program called Care Coordination for Health Promotion and Activities in Parkinson’s Disease (CHAPS). To be eligible, patients had to have at least two visits with a primary diagnosis of idiopathic Parkinson’s disease (ICD-9 code: 332.0) at one of five Veterans Affairs Medical Centers in the southwestern United States from 2010 to 2014. The program consists of telephone assessments, evidence-based protocols, and tools to enhance patient self-management, care planning, and coordination of care across providers, including an electronic database to support and track coordination of care. Our mixed-methods study employs a randomized, controlled trial design to test whether the CHAPS intervention improves performance in 38 quality measures among an analytic sample of 346 patients. The 38 quality measures are categorized into overarching areas of communication, education, and continuity; regulatory reporting; diagnosis; periodic assessment; medication use; management of motor and non-motor symptoms; use of non-pharmacological approaches and therapies; palliative care; and health maintenance. Secondary outcomes are patient health-related quality of life, self-efficacy, and perceptions of care quality. We are also evaluating the extent of the CHAPS Program implementation and measuring program costs and impacts on health services utilization, in order to perform a analysis of the CHAPS program from the perspective of the Veterans Health Administration (VA). Outcomes are assessed by interviewer-administered surveys collected at baseline and at 6, 12, and 18 months, and by medical record chart abstractions. Analyses will be intention-to-treat. The CHAPS Program is poised for dissemination within the VA National Parkinson’s Disease Research, Education, and Clinical Center Consortium if demonstrated efficacious. ClinicalTrials.gov NCT01532986 ; registered on January 13, 2012.