Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs.

BACKGROUND: Human milk-based human milk fortifier (HMB-HMF) makes it possible to provide an exclusive human milk diet (EHMD) to very low birth weight (VLBW) infants in neonatal intensive care units (NICUs). Before the introduction of HMB-HMF in 2006, NICUs relied on bovine milk-based human milk fortifiers (BMB-HMFs) when mother's own milk (MOM) or pasteurized donor human milk (PDHM) could not provide adequate nutrition. Despite evidence supporting the clinical benefits of an EHMD (such as reducing the frequency of morbidities), barriers prevent its widespread adoption, including limited health economics and outcomes data, cost concerns, and lack of standardized feeding guidelines. METHODS: Nine experts from seven institutions gathered for a virtual roundtable discussion in October 2020 to discuss the benefits and challenges to implementing an EHMD program in the NICU environment. Each center provided a review of the process of starting their program and also presented data on various neonatal and financial metrics associated with the program. Data gathered were either from their own Vermont Oxford Network outcomes or an institutional clinical database. As each center utilizes their EHMD program in slightly different populations and over different time periods, data presented was center-specific. After all presentations, the experts discussed issues within the field of neonatology that need to be addressed with regards to the utilization of an EHMD in the NICU population. RESULTS: Implementation of an EHMD program faces many barriers, no matter the NICU size, patient population or geographic location. Successful implementation requires a team approach (including finance and IT support) with a NICU champion. Having pre-specified target populations as well as data tracking is also helpful. Real-world experiences of NICUs with established EHMD programs show reductions in comorbidities, regardless of the institution's size or level of care. EHMD programs also proved to be cost effective. For the NICUs that had necrotizing enterocolitis (NEC) data available, EHMD programs resulted in either a decrease or change in total (medical + surgical) NEC rate and reductions in surgical NEC. Institutions that provided cost and complications data all reported a substantial cost avoidance after EHMD implementation, ranging between $515,113 and $3,369,515 annually per institution. CONCLUSIONS: The data provided support the initiation of EHMD programs in NICUs for very preterm infants, but there are still methodologic issues to be addressed so that guidelines can be created and all NICUs, regardless of size, can provide standardized care that benefits VLBW infants.

Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study.

A pilot clinical study was conducted that compared the peripheral oxygen saturation (SpO2) targeting performance of an automatic oxygen control system with manual oxygen control, which is the standard of care for preterm and low birth weight infants on high-flow nasal cannula (HFNC). The new oxygen control device studied was used to automatically adjust the fraction of inspired oxygen (FiO2) according to a desired SpO2 target setpoint and measured feedback signals including the SpO2 and other signals. A crossover study was designed with several endpoints including the comparison of the percentage of time that the SpO2 was within the target range with the automatic oxygen control device versus manual oxygen control. Other metrics were also compared to assess the performance of the system including the number of bradycardia events. The pilot study included six patients that fit the inclusion criteria. The results showed that there were improvements in all of the measured outcomes considered including statistically significant improvements in the number of bradycardia events during the period when the automatic oxygen control device was used.

Rates of Comorbidities in Very Low Birth Weight Infants Fed an Exclusive Human Milk Diet Versus a Bovine Supplemented Diet.

Background: Our level III neonatal intensive care unit (NICU) implemented the use of an exclusive human milk diet (EHD) and sought to determine its effect on the severe co-morbidities of preterm infants as well as the potential cost-savings due to the anticipated reduction in these co-morbidities. Methods: A retrospective cohort study was completed to determine if an EHD statistically decreased the rate of co-morbidities including length of stay (LOS), days on total parental nutrition (TPN), rates of late onset sepsis, necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and severe retinopathy of prematurity (ROP). Results: An EHD significantly decreased the odds of severe ROP (adjusted odds-ratio (aOR)=0.349; 95%CI [0.156, 0.739]; p=0.008) and late onset sepsis (aOR=0.323; 95%CI [0.123, 0.768]; p=0.014). Analysis of cost-effectiveness of an EHD relative to a BSD based on the incremental costs of these co-morbidities determined the net loss in direct hospital costs per patient were estimated to be $420 in 2016 US dollars; however, given the long-term health-care costs and non-pecuniary damages from the co-morbidities of severe ROP and sepsis this net loss appears negligible. Conclusion: This study found that an EHD significantly decreased the odds of severe ROP and late onset sepsis; though not significant, there was a positive trend in decreasing cases of medical NEC; our surgical NEC rates dropped to 0. The benefits of human milk are vital, and the costs are nominal.

Comparison of Automated and Manual Peripheral Oxygen Saturation Control Applied to One Human Subject at a High Target Range.

Newborn infants, mainly those born prematurely, often require respiratory support with a varying concentration of the fraction of inspired oxygen (FiO$_{\mathbf {2}}$) to keep the peripheral oxygen saturation (SpO$_{\mathbf {2}}$) within the desired range to prevent adverse health effects due to both high and low SpO$_{\mathbf {2}}$. Manual adjustment, by nurses, is the common practice. However, the efficacy of the manual control is questionable. A novel automatic controller is evaluated clinically with application to one human subject at a high target SpO$_{\mathbf {2}}$. The automatic controller demonstrated the ability to improve oxygen saturation control over the everyday routine manual control by increasing the proportion of time where SpO$_{\mathbf {2}}\textbf{v}$alues were within the desired range.