Early feeding, skin-to-skin contact, and dextrose gel have been independently shown to promote breastfeeding and decrease NICU admission for neonatal hypoglycemia. We combined these interventions to ...decrease NICU admissions for asymptomatic hypoglycemia and increase exclusive breastfeeding rates.
The IHI Model for Improvement was used to design a bundle including feeding within 1 h of birth, 1 h of uninterrupted skin-to-skin within 2 h of birth, and administration of buccal 40% dextrose gel for hypoglycemic infants.
Utilization of dextrose gel was 94% following implementation. There were no trends in exclusive breastfeeding at discharge or NICU admissions for asymptomatic hypoglycemia. Post hoc multivariate analysis identified cesarean delivery as an independent risk factor for compliance failure and failure of exclusive breastfeeding but not for NICU admission.
Despite high compliance with dextrose gel utilization, there was no change in exclusive breastfeeding at discharge or NICU admission rates for asymptomatic hypoglycemia.
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.
Objective/Aim: To incorporate a neonatal hypoglycemia prevention bundle into preexisting newborn hypoglycemia algorithms and assess effects on exclusive breastfeeding success and NICU admission ...rates. Background: Transient neonatal hypoglycemia affects up to 15% of newborns and is associated with an increased risk of NICU admission, geographical separation from parents, and interruption of breastfeeding goals. Early initiation of feeds, early skin-to-skin contact, and dextrose gel supplementation have all been independently shown to promote exclusive breastfeeding and decrease hypoglycemia related complications including NICU admission. Quality Improvement Methods: Multicenter implementation of a neonatal hypoglycemia bundle. The bundle sub-aims included initiation feeds within 1 hour of birth, 1 hour uninterrupted skin-to-skin within 2 hours of birth, and initiation of glucose monitoring within 2 hours of birth. In addition, the bundle implemented the addition of buccal 40% dextrose gel (0.5mL/kg/dose) to existing hospital hypoglycemia management protocols SMART aim assessments included: 1. Implementation compliance of entire bundle above 70%, 2. Reduce absolute NICU admission rate for asymptomatic hypoglycemia by 5%, and 3. Improve absolute exclusive breastfeeding rate at discharge for high risk infants by 10%. Results: From January 2017 through January 2018, 474 and 363 infants were screened pre-and immediate post-implementation respectively. Documented compliance of early feeding, skin to skin, and early glucose checks post-implementation was 46% total compliance. Exclusive breastfeeding increased from 39% to 49%. NICU admission rates decreased from 10% to 8%. CQI Rapid PDSA cycles initiated targeting sub aim compliance above 90% to achieve total bundle compliance above 70%. Statistical process control charts using standard interpretation rules were used to monitor for improvement in key aims. Conclusions: Implementation of a hypoglycemia bundle to existing hospital screening protocols did not provide clinically significant reduction in NICU admission rate for asymptomatic hypoglycemia across sites. Exclusive breastfeeding at discharge did achieve a clinically significant increase after bundle implementation, potentially through avoidance of early formula supplementation or avoided NICU admission.
To determine the effect of implementing a 2015 policy for the screening, prevention, and management of metabolic bone disease for very low birth weight (VLBW) infants in two Level IV NICUs.
...Retrospective cohort study of VLBW infants in the 2 years prior to (2013-2014) and after (2016-2017) policy implementation.
We identified 316 VLBW infants in 2013-2014 and 292 in 2016-2017 who met study criteria. After policy implementation, vitamin D supplementation began earlier (20.1 ± 15.5 days vs 30.2 ± 20.1 days, p < 0.0005), the percentage of infants with alkaline phosphatase obtained increased (89.7% vs 76.3%, p < 0.0005), while the percentage of infants with alkaline phosphatase >800 IU/L (11.7 vs 4.5%, p = 0.0001) and phosphorous <4 mg/dL (14.2% vs 7.9%, p = 0.014) fell significantly.
After policy implementation, vitamin D supplementation began significantly earlier and the rate of detecting abnormal biochemical markers of metabolic bone disease decreased significantly.
There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with ...parents' decisional conflict and ultimately their decision to enroll.
This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24-28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire.
Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents' knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant's doctor.
Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.
To compare the amount of time required to collect a blood specimen, the number of heel punctures required, and the rate of hematology re-collections required when using a Monolet lancet vs a ...Tenderfoot Preemie device.
Randomized, two-group, quasi-experimental.
Neonates with a birth weight >800 gm were eligible to participate in the study. Twenty subjects were randomized to the Monolet lancet (control) group and 20 to the Tenderfoot Preemie (experimental) group. A total of 157 blood specimens was collected, 89 of which were for hematology testing.
For this sample population of preterm infants, less collection time was required, fewer heel punctures were necessary, and a lower re-collection rate occurred with use of the Tenderfoot Preemie than with use of the Monolet lancet.
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