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 Experiences of Genetic Testing.

Genetic testing is increasingly used in clinical practice in the neonatal period, including in NICUs. This testing may have psychological consequences for parents. To best support families, neonatal clinicians should be aware of the various ways in which parents view and respond to genetic testing. In this review, we summarize research on the parental experience of having a newborn infant undergo genetic testing.

Surgical History and Outcomes in Trisomy 13 and 18: A Thirty-year Review.

BACKGROUND: Patients with Trisomy 13(T13) and 18(T18) have many comorbidities that may require surgical intervention. However, surgical care and outcomes are not well described, making patient selection and family counseling difficult. Here the surgical history and outcomes of T13/ T18 patients are explored. METHODS: A retrospective review of patients with T13 or T18 born between 1990 and 2020 and cared for at a tertiary children's hospital (Riley Hospital for Children, Indianapolis IN) was conducted, excluding those with insufficient records. Primary outcomes of interest were rates of mortality overall and after surgery. Factors that could predict mortality outcomes were also assessed. RESULTS: One-hundred-seventeen patients were included, with 65% T18 and 35% T13. More than half of patients(65%) had four or more comorbidities. Most deaths occurred by three months at median 42.0 days. Variants of classic trisomies (mosaicism, translocation, partial duplication; p = 0.001), higher birth weight(p = 0.002), and higher gestational age(p = 0.01) were associated with lower overall mortality, while cardiac(p = 0.002) disease was associated with higher mortality. Over half(n = 64) underwent surgery at median age 65 days at time of first procedure. The most common surgical procedures were general surgical. Median survival times were longer in surgical rather than nonsurgical patients(p<0.001). Variant trisomy genetics(p = 0.002) was associated with lower mortality after surgery, while general surgical comorbidities(p = 0.02), particularly tracheoesophageal fistula/esophageal atresia(p = 0.02), were associated with increased mortality after surgery. CONCLUSIONS: Trisomy 13 and 18 patients have vast surgical needs. Variant trisomy was associated with lower mortality after surgery while general surgical comorbidities were associated with increased mortality after surgery. Those who survived to undergo surgery survived longer overall. LEVEL OF EVIDENCE: III.

What Should an Intern Do When She Disagrees With the Attending?

Disagreements, including those between residents and attending physicians, are common in medicine. In this Ethics Rounds article, we present a case in which an intern and attending disagree about discharging the patient; the attending recommends that the patient be hospitalized longer without providing evidence to support his recommendation. Commentators address different aspects of the case. The first group, including a resident, focus on the intern's potential moral distress and the importance of providing trainees with communication and conflict resolution skills to address inevitable conflicts. The second commentator, a hospitalist and residency program director, highlights the difference between residents' decision ownership and attending physicians' responsibilities and the way in which attending physicians' responsibilities for patients can conflict with their roles as teachers. She also highlights a number of ways training programs can support both trainees and attending physicians in addressing conflict, including cultivating a learning environment in which questioning is encouraged and celebrated. The third commentator, a hospitalist, notes the importance of shared decision-making with patients and their parents when decisions involve risk and uncertainty. Family-centered rounds can facilitate shared decision-making.

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.

Historical Perspectives: Unsilencing Suffering: Promoting Maternal Mental Health in Neonatal Intensive Care Units.

Mothers of infants in the NICU suffer higher rates of psychological distress, anxiety, and depression compared with the general population. Often, their mental health concerns remain underidentified and undertreated, which can have deleterious effects on the offspring, both in short-term outcomes while in the NICU as well as long-term neurodevelopmental and behavioral outcomes. In this review, we present an overview of existing empirical evidence about how maternal mental health affects the health of infants, special considerations regarding the mental health needs of NICU mothers, and the findings about existing and developing interventions to address mental health concerns in this vulnerable population.

Facilitators of and barriers to successful teamwork during resuscitations in a neonatal intensive care unit.

OBJECTIVE: Effective teamwork is essential in high-risk healthcare delivery environments. In this study, we aimed to identify facilitators of and barriers to successful teamwork during resuscitations in the NICU Study Design: 36 in-situ interprofessional simulation sessions were held in a level 4 NICU. Each session was followed by a debriefing where staff talked about the simulation scenario but also about their prior experiences during resuscitations in the NICU. Using content analysis, we analyzed the transcriptions of debriefings to address the study aims. RESULT: Participant responses yielded three major themes: communicating well, getting tasks done well, and working well together. Each main theme had subthemes. CONCLUSION: Teamwork is a complex process that is enhanced and hindered by a variety of factors. The factors identified in this study can be used to enhance relationship-based teamwork training programs. Future research is needed to determine which teamwork behaviors are most associated with patient outcomes.

Ethics education in neonatal-perinatal medicine in the United States.

Neonatology is one of the specialties that has immensely benefited from advances in medical technology in the last few decades. These advances have paralleled the rise of the civil rights movements and wider recognition of individual rights. As a result, ethical decision-making has become more complex, involving patients, parents, members of the health care team, and society in general. This has created a need for formal ethics education in neonatal-perinatal medicine fellowship programs. In this article, we briefly explore the current published data on ethics education in pediatric residency and neonatal-perinatal medicine fellowship programs. Then, we discuss the questions an academic educator may face while developing an ethics curriculum in his/her medical institution. Finally, we present the ethics curriculum that we developed in our neonatal-perinatal medicine fellowship program.

Specificity and sensitivity of hemosiderin-laden macrophages in routine bronchoalveolar lavage in children.

CONTEXT: The presence of iron or hemosiderin in macrophages obtained in routine bronchoalveolar lavage is considered crucial in the diagnosis of the clinical syndrome of hemosiderosis. However, there do not appear to be any data on the sensitivity and specificity of the finding of hemosiderin-laden macrophages (HLMs) in bronchoalveolar lavage in children. OBJECTIVE: To review data from bronchoalveolar lavage studies done in children to correlate the presence of HLMs with pneumonia and hemosiderosis and to determine what proportion of HLMs has the optimal sensitivity and specificity for the diagnosis of hemosiderosis. DESIGN: One hundred ten bronchoalveolar lavage specimens obtained via flexible bronchoscopy were reviewed retrospectively. The data collected for demographics, indication for the bronchoscopy, diagnosis of pneumonia, anemia, and bronchoscopy and bronchoalveolar lavage findings were compared between patients diagnosed with hemosiderosis and those diagnosed with other diseases. RESULTS: Six patients were diagnosed with hemosiderosis by clinical findings, lung biopsy, or autopsy. There were no statistical differences in pneumonia (P > .99), anemia (P > .99), or coughing (P = .08) between patients with hemosiderosis and other patients. Hemoptysis was the only symptom that was significantly different between the 2 groups (P = .04). The mean HLM index for patients with hemosiderosis was 56% +/- 16.17% and for other patients, 7.5% +/- 10.74% (P < .001). A HLM index of 35% gave a sensitivity of 1% and a specificity of .96%. CONCLUSIONS: These results confirm a strong association between HLM index and diagnosis of hemosiderosis in a pediatric population. Availability of this HLM index will result in accurate and timely diagnosis of pulmonary hemosiderosis, which may influence treatment and long-term prognosis.