A quality improvement initiative for neonatal hypoglycemia screening and management in a level III neonatal intensive care unit.

OBJECTIVE: To bring screening and management of neonatal hypoglycemia in alignment with the 2011 AAP hypoglycemia clinical report METHODS: A multidisciplinary team developed a quality improvement initiative for neonatal hypoglycemia in neonates ≥35 weeks gestational age in a Level III neonatal intensive care unit between July 2020 and December 2021. A key driver diagram identified interventions for plan-do-study-act testing with corresponding measures to implement a hypoglycemia management protocol and improve adherence to AAP guidelines. RESULTS: Time to first blood glucose measurement increased from 49.8 to 122.7 min of life and time to first enteral feed decreased from 14.2 to 3.6 h of life. Neonates receiving intravenous dextrose decreased from 97.1 to 24.7% and discharge rates as a mother-neonate dyad increased from 35 to 62.4%. CONCLUSIONS: Adherence to the AAP guidelines improved during testing and implementation of a hypoglycemia protocol and was associated with an increased mother-neonate dyad discharge rate.

Evaluating visual imagery for participant understanding of research concepts in genomics research.

Informed consent is crucial for participant understanding, engagement, and partnering for research. However, current written informed consents have significant limitations, particularly for complex topics such as genomics and biobanking. Our goal was to identify how participants visually conceptualize terminology used in genomics and biobanking research studies, which might provide a novel approach for informed consent. An online convenience sample was used from May to July 2020 to collect data. Participants were asked to draw 10 randomly chosen words out of 32 possible words commonly used in consent forms for genomics and biobanking research. An electronic application captured drawings that were downloaded into a qualitative software program for analysis. A total of 739 drawings by 269 participants were captured. Participants were mostly female (61.3%), eight different race/ethnicities were represented (15.6% Black, 13.8% Hispanic), and most had some college education (68.8%). Some words had consistent visual themes such as different types of risky activities for risk or consistent specific images such as a double helix for DNA. Several words were frequently misunderstood (e.g., ascend for assent), while others returned few submissions (e.g., phenotype or whole genome sequencing). We found that although some words used in genomics and biobanking research were visually conceptualized in a common fashion, but misunderstood or less well-known words had no, few, or mistaken drawings. Future research can explore the incorporation of visual images to improve participant comprehension during consent processes, and how to utilize visual imagery to address more challenging concepts.

Culturally competent care in the neonatal intensive care unit, strategies to address outcome disparities.

In the past two years, we have witnessed social unrest, the unequal effects of a pandemic across our society, and a focus on how systems in the United States produce unequal outcomes along racial and cultural divides. With increased national awareness, there has also been a call for change in healthcare, specifically racial inequities in Neonatal Intensive Care Unit (NICU) outcomes (1). While race may be a data point used to classify outcomes, it has no basis in biology, and merely identifying it does not make it simple to address. To address these inequities we need to look past the social construct of race and to the social aspects of our care in the NICU. Focusing on small and large changes that we can make as individuals, units, and as a specialty that can improve the care and outcomes of this at-risk patient population. This perspective focuses on culturally congruent care, trauma-informed care, and other approaches to reduce disparities in neonatal outcomes.

Addressing ethical and laboratory challenges for initiation of a rapid whole genome sequencing program.

Rapid whole genome sequencing (rapid WGS) is a powerful diagnostic tool that is becoming increasingly practical for widespread clinical use. However, protocols for its use are challenging to implement. A significant obstacle to clinical adoption is that laboratory certification requires an initial research development phase, which is constrained by regulations from returning results. Regulations preventing return of results have ethical implications in cases which might impact patient outcomes. Here, we describe our experience with the development of a rapid WGS research protocol, that balanced the requirements for laboratory-validated test development with the ethical needs of clinically relevant return of results.

Parental Enrollment Decision-Making for a Neonatal Clinical Trial.

OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.

Importance: It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. Objective: To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. Design, Setting, and Participants: This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. Exposure: Parental choice of enrollment in neonatal clinical trial. Main Outcomes and Measures: Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. Results: Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. Conclusions and Relevance: In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.

Improving preoperative identification of infants at risk for severe retinopathy of prematurity.

OBJECTIVE: To increase preoperative identification of at-risk infants for severe Retinopathy of prematurity (ROP) to >95% by August 2016, with a secondary aim of reducing the number of infants with 100% intraoperative peripheral oxygen saturation (SpO2) during the same time. STUDY DESIGN: Prospective quality improvement project centered on preterm surgical infants admitted to Primary Children's Hospital (n = 41). Preoperative ROP risk identification rates were analyzed using an annotated run chart, intraoperative SpO2 and laser intervention were compared using un-paired t test. RESULTS: Preoperative identification of ROP risk increased from 60 to 100% and no infant was exposed to 100% SpO2 intraoperatively during the study period. The incidence of laser intervention in this population decreased by 45% from 22 to 12% (p = 0.21). CONCLUSION: Simplifying our preoperative handoff increased our rates of correct identification and communication ROP risk in preterm infants while decreasing exposure to 100% SpO2.

Assessing the Surgical Experience to Identify Risk Factors Associated with Severe Retinopathy of Prematurity and Laser Intervention.

BACKGROUND: Retinopathy of prematurity (ROP) is a known complication of preterm birth and one of the leading causes of blindness. Known risk factors include low gestational age (GA), birth weight, and oxygen exposure. It is unknown if there are surgical risk factors associated with severe ROP. OBJECTIVES: Identify risk factors of a neonatal surgical exposure associated with laser therapy for ROP. METHODS: Institutional review of 76 infants with GA ≤27 weeks or birth weight ≤800 g. Infant demographics and details of surgical experience were collected. Infants who underwent a surgical procedure were analyzed to identify risk factors associated with laser treatment for severe ROP. Surgical and nonsurgical infants were compared to assess if the rate of laser intervention differed among institutions/published data. Data were analyzed using the Mann-Whitney U test, unpaired t test, OR and Fischer's exact test. RESULT: Out of 49 surgical infants, 11 underwent laser intervention. Infants undergoing laser had surgery at an earlier postmenstrual age (PMA; 31.5 [29.3-39.4] weeks vs. 38.1 [31.3-42.5] weeks, p = 0.01), were more likely to have an exploratory laparotomy (adjusted odds ratio 1.3 [1.04-1.64], p = 0.02), and to undergo more surgical procedures (3 vs. 2, p = 0.04). CONCLUSION: At our institution, preterm infants who undergo a surgical procedure prior to 32 weeks PMA and those having ≥3 surgeries were at a higher risk for progressing to laser intervention. Additional studies with larger sample sizes are needed to assess if the risk factors we have identified remain significant and to identify other possible risk factors.