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.

Effect on metabolic bone disease markers in the neonatal intensive care unit with implementation of a practice guideline.

OBJECTIVES: 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. STUDY DESIGN: Retrospective cohort study of VLBW infants in the 2 years prior to (2013-2014) and after (2016-2017) policy implementation. RESULTS: 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. CONCLUSIONS: After policy implementation, vitamin D supplementation began significantly earlier and the rate of detecting abnormal biochemical markers of metabolic bone disease decreased significantly.

Evaluating the effects of a neonatal hypoglycemia bundle on NICU admission and exclusive breastfeeding.

OBJECTIVE: 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. PROJECT DESIGN: 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. RESULTS: 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. CONCLUSIONS: Despite high compliance with dextrose gel utilization, there was no change in exclusive breastfeeding at discharge or NICU admission rates for asymptomatic hypoglycemia.

Informed consent for a neonatal clinical trial: parental experiences and perspectives.

OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.