Perinatal depression and its impact on infant outcomes and maternal-nurse SMS communication in a cohort of Kenyan women.

BACKGROUND: Perinatal depression is broadly defined as depressive symptoms during pregnancy or within the 12 months following delivery, affecting approximately 20-25% of pregnant and postpartum women in low- and middle-income countries. The wide accessibility of mobile phones allows mobile health (mHealth) interventions to be considered a solution to identify perinatal depression and provide appropriate referrals for treatment. This study, nested in a larger SMS communication project, examined the prevalence and correlates of perinatal depression, determined the association between antenatal depression and infant morbidity and mortality, and compared SMS communication patterns between women with and without perinatal depression. METHODS: This was a prospective longitudinal cohort study of pregnant women seeking antenatal services at two public sector health clinics in Kenya. SMS messages were sent to participants with educational content related to their pregnancy and infant health and two-way SMS communication occurred with a nurse. Sociodemographic and obstetric characteristics, SMS messaging behaviors, infant health status, and depressive symptoms were assessed by a standardized questionnaire administered at enrollment (30-36 weeks gestation) and follow-up (14 weeks postpartum). Generalized estimating equation (GEE) with Poisson link was used to evaluate correlates of perinatal depressive symptoms, infant outcomes, and frequency of SMS messaging. RESULTS: Of the 572 women with complete follow-up information, 188 (32.9%) screened positive for elevated depressive symptoms (≥10 by EPDS scale) at some time point during pregnancy or postpartum. The strongest predictors of any depressive symptoms included interpersonal abuse during pregnancy, fewer years of schooling, and maternal unemployment. Antenatal depressive symptoms were associated with an increased risk of infant illness or hospitalization (RR = 1.12, 95% CI: 1.11, 1.13). Women with antenatal or persistent perinatal depressive symptoms sent fewer SMS messages during the study period than their counterparts without depression. CONCLUSIONS: Prevalence of elevated perinatal depressive symptoms was high in this cohort of Kenyan women. Our findings highlight the importance of screening perinatal women for experiences of symptoms of depression as well as abuse. Differences in messaging frequency between women with vs. without depressive symptoms presents an opportunity to provide more tailored support for those perinatal depression.

International Experience of US Pediatricians and Level of Comfort Caring for Immigrant Children and Children Traveling Internationally.

OBJECTIVE: To determine whether international experience is associated with greater comfort in providing care to US children who are immigrants, refugees, and traveling internationally. STUDY DESIGN: Following enrollment into the 2018 American Board of Pediatrics Maintenance of Certification program, general pediatricians and subspecialists received a voluntary, online survey with questions about their experience and self-reported comfort caring for immigrant, refugee, and internationally traveling children and previous international experiences. Using multivariable logistic regression, we examined how previous international experiences, and other personal characteristics, were associated with self-reported comfort. RESULTS: A total of 5461 eligible participants completed the survey; 76.3%, (n = 4168) reported caring for immigrant children, 35.8% (n = 1957) cared for refugee children, and 79.8% (n = 4358) cared for children traveling internationally. High levels of comfort caring for immigrant children were reported by 68.5% (n = 3739), for refugee children by 50.1% (n = 2738), and for children traveling internationally by 72.7% (n = 3968). One-third of respondents (34.1%, n = 1866) reported past international experiences. In multivariable analysis, respondents with previous international experience and of Hispanic origin were significantly more likely to report high levels of comfort caring for all 3 populations. CONCLUSIONS: The majority of pediatricians report caring for children in the US who are immigrants, refugees, and traveling internationally, and previous international experience was associated with greater comfort with care. Training programs and professional organizations should consider ways to encourage a more diverse workforce and to support all pediatricians in achieving the skills and confidence required to care for children in our highly mobilized society.

The Silverman Andersen respiratory severity score in the delivery room predicts subsequent intubation in very preterm neonates.

Treatment with mechanical ventilation is associated with chronic lung disease and poor neurologic outcomes in very premature neonates. Surfactant replacement in patients with respiratory distress syndrome reduces need for mechanical ventilation and may be most beneficial when performed early.

Characterization of a severe case of PIK3CA-related overgrowth at autopsy by droplet digital polymerase chain reaction and report of PIK3CA sequencing in 22 patients.

PIK3CA-related overgrowth spectrum (PROS) refers to a group of disorders of segmental overgrowth of a wide variety of tissues as well as venous and lymphatic malformations. Clinical and molecular diagnosis can be challenging due to phenotypic heterogeneity and difficulties detecting low-level mosaicism using standard methods. Here, we report a patient with a severe presentation of PIK3CA-related overgrowth with analysis of 27 posthumously collected tissues by droplet digital polymerase chain reaction (PCR) at autopsy. This patient had a complicated medical course, with coagulopathy, ischemic brain injury, and sepsis resulting in multi-organ failure and death at age 2 months despite sirolimus therapy. Five of the 27 tissues analyzed possessed a mosaic PIK3CA mutation (p.E545K), with mutation levels ranging from 3 to 20% across affected tissues. We found no correlation between tissue-specific disease severity and mutation levels, likely reflecting sampling limitations. We also tested a series of 22 individuals with somatic overgrowth and/or vascular-lymphatic malformations using a targeted next generation sequencing panel and found PIK3CA mutations in nine individuals, identifying three novel PIK3CA variants. This report expands the clinical and molecular spectrum of PROS, emphasizes that different molecular methods can be complimentary in the diagnosis of these disorders, and highlights the risk of coagulopathy in a subset of patients with PIK3CA-related overgrowth.

Identifying High-Risk Children in the Emergency Department.

PURPOSE: Early warning scores (EWS) identify high-risk hospitalized patients prior to clinical deterioration; however, their ability to identify high-risk pediatric patients in the emergency department (ED) has not been adequately evaluated. We sought to determine the association between modified pediatric EWS (MPEWS) in the ED and inpatient ward-to-pediatric intensive care unit (PICU) transfer within 24 hours of admission. METHODS: This is a case-control study of 597 pediatric ED patients admitted to the inpatient ward at Seattle Children's Hospital between July 1, 2010, and December 31, 2011. Cases were children subsequently transferred to the PICU within 24 hours, whereas controls remained hospitalized on the inpatient ward. The association between MPEWS in the ED and ward-to-PICU transfer was determined by chi-square analysis. RESULTS: Fifty children experienced ward-to-PICU transfer within 24 hours of admission. The area under the receiver-operator characteristic curve was 0.691. Children with MPEWS > 7 in the ED were more likely to experience ward-to-PICU transfer (odds ratio 8.36, 95% confidence interval 2.98-22.08); however, the sensitivity was only 18.0% with a specificity of 97.4%. Using MPEWS >7 for direct PICU admission would have led to 167 unnecessary PICU admissions and identified only 9 of 50 patients who required PICU care. CONCLUSIONS: Elevated MPEWS in the ED is associated with increased risk of ward-to-PICU transfer within 24 hours of admission; however, an MPEWS threshold of 7 is not sufficient to identify more than a small proportion of ward-admitted children with subsequent clinical deterioration.

Demographics, clinical characteristics and neonatal outcomes in a rural Ugandan NICU.

BACKGROUND: Ninety-six percent of the world's 3 million neonatal deaths occur in developing countries where the majority of births occur outside of a facility. Community-based approaches to the identification and management of neonatal illness have reduced neonatal mortality over the last decade. To further expand life-saving services, improvements in access to quality facility-based neonatal care are required. Evaluation of rural neonatal intensive care unit referral centers provides opportunities to further understand determinants of neonatal mortality in developing countries. Our objective was to describe demographics, clinical characteristics and outcomes from a rural neonatal intensive care unit (NICU) in central Uganda from 2005-2008. METHODS: The NICU at Kiwoko hospital serves as a referral center for three rural districts of central Uganda. For this cross sectional study we utilized a NICU clinical database that included admission information, demographics, and variables related to hospital course and discharge. Descriptive statistics are reported for all neonates (<28 days old) admitted to the NICU between December 2005 and September 2008, disaggregated by place of birth. Percentages reported are among neonates for which data on that indicator were available. RESULTS: There were 809 neonates admitted during the study period, 68% (490/717) of whom were inborn. The most common admission diagnoses were infection (30%, 208/699), prematurity (30%, 206/699), respiratory distress (28%, 198/699) and asphyxia (22%, 154/699). Survival to discharge was 78% (578/745). Mortality was inversely proportional to birthweight and gestational age (P-value test for trend <0.01). This was true for both inborn and outborn infants (p < 0.01). Outborn infants were more likely to be preterm (44%, (86/192) vs. 33%, (130/400), P-value <0.01) and to be low birthweight (58%, (101/173) vs. 40%, (190/479), P-value <0.01) than inborn infants. Outborn neonates had almost twice the mortality (33%, 68/208) as inborn neonates (17%, 77/456) (P-value <0.01). CONCLUSIONS: Understanding determinants of neonatal survival in facilities is important for targeting improvements in facility based neonatal care and increasing survival in low and middle income countries.

Characterization of health care provider attitudes toward parental involvement in neonatal resuscitation-related decision making in Mongolia.

The aim of this study was to characterize attitudes and practices among health care providers (HCPs) in Mongolia regarding parental involvement in neonatal resuscitation (NR)-related decisions. A voluntary, anonymous questionnaire was administered to 210 HCPs across 19 of 21 Mongolia provinces. Eligible HCPs included midwives, neonatologists, pediatricians, and obstetricians involved in neonatal-perinatal care in both rural and urban hospitals. A total of 210 pediatric HCPs were surveyed and 100 % completed all questions (response rate 100 %). Despite the absence of nation-wide guidelines, NR is uniformly performed at 32-weeks gestation across HCP professions and across rural/urban settings. Most HCPs (67 %) indicate that parents should be counseled about resuscitation, but only 9 % ask the parents if they want their extremely premature child resuscitated and only 17 % counsel the parents prior to birth of an at-risk infant. Most HCPs (72 %) prefer to unilaterally decide when to withdraw NR, and only 28 % indicated that both parents should be involved in the decision. Following a newborn's death, 75 % of all HCPs reported that they do explain the death to parents, although only 28 % reported receiving any training in parental grief counseling. For HCPs in Mongolia, a discrepancy exists between the perceived value of parental involvement and the actual practice of NR-related counseling. This report is a necessary first step toward understanding the factors that influence NR-related practices in Mongolia, and may serve as model for collecting these types of data in other low and middle income countries.

Transmission of negative biases through social commentary included in neonatal intensive care unit progress notes.

OBJECTIVE: To determine how the perception of families elicited after reading progress note social commentary differs by patient race. STUDY DESIGN: We retrospectively performed content analysis of social commentary in physician progress notes for neonatal intensive care unit patients hospitalized from 2018-2019. Neonatologists blinded to patient race rated how commentary impacted their perception of the patient's family on a 5-point Likert scale. Frequency of negative ratings was compared across reported race using chi-squared tests. RESULTS: We reviewed charts of 460 neonates. In total, 225 (49%) contained social commentary beyond parents' names. Twelve neonatologists rated how commentaries impacted their perception of the patient's family; 79%, 18%, and 3% were rated neutrally, negatively, and positively, respectively. Frequency of negative ratings was significantly greater among American Indian/Alaska Native than other patients (35% vs. 22%, p < 0.001). CONCLUSIONS: Physician documentation of social commentary in patient notes may reflect and perpetuate implicit biases that contribute to race-based healthcare disparities.

Outborn newborns drive birth asphyxia mortality rates-An 8 year analysis at a rural level two nursery in Uganda.

Birth asphyxia is a leading cause of global neonatal mortality. Most cases occur in low- and middle- income countries and contribute to half of neonatal deaths in Uganda. Improved understanding of the risk factors associated with mortality among these patients is needed. We performed a retrospective cohort study of a clinical database and report maternal demographics, clinical characteristics and outcomes from neonates with birth asphyxia at a Ugandan level two unit from 2014 through 2021. "Inborn" patients were born at the hospital studied and "outborn" were born at another facility or home and then admitted to the hospital studied. Doctors assigned the patient's primary diagnosis at death or discharge. We performed a Poisson model regression of factors associated with mortality among patients with asphyxia. The study included 1,565 patients with birth asphyxia and the proportion who were outborn rose from 26% to 71% over eight years. Mortality in asphyxiated patients increased over the same period from 9% to 27%. Factors independently associated with increased death included outborn birth location (ARR 2.1, p<0.001), admission in the year 2020 (ARR 2.4, p<0.05) and admission respiratory rate below 30bpm (RR 3.9, p<0.001), oxygen saturation <90% (ARR 2.0, p<0.001) and blood sugar >8.3 mmol/L (RR 1.7, p<0.05). Conversely, a respiratory rate >60bpm was protective against death (ARR 0.6, p<0.05). Increased birth asphyxia mortality at this referral unit was associated with increasing admission of outborn patients. Patients born at another facility and transferred face unique challenges. Increased capacity building at lower-level birth facilities could include improved staffing, training and equipment for labor monitoring and newborn resuscitation as well as training on the timely identification of newborns with birth asphyxia and resources for transfer. These changes may reduce incidence of birth asphyxia, improve outcomes among birth asphyxia patients and help meet global targets for newborn mortality.

Burnout During the COVID-19 Pandemic: A Report on Pediatric Residents.

BACKGROUND AND OBJECTIVE: The Pediatric Resident Burnout and Resilience Consortium (PRB-RSC) has described the epidemiology of burnout in pediatric residents since 2016. We hypothesized burnout rates during the pandemic would increase. We explored resident burnout during the COVID-19 pandemic and its relationship to resident perception of workload, training, personal life, and local COVID burden. METHODS: Since 2016, PRB-RSC has sent an annual, confidential survey to over 30 pediatric and medicine-pediatrics residencies. In 2020 and 2021, seven questions were added to explore the relationship of COVID-19 and perceptions of workload, training, and personal life. RESULTS: In 2019, 46 programs participated, 22 in 2020, and 45 in 2021. Response rates in 2020 (n = 1055, 68%) and 2021(n = 1702, 55%) were similar to those of previous years (P = .09). Burnout rates in 2020 were significantly lower than in 2019 (54% vs 66%, P < .001) but returned to pre-COVID levels in 2021 (65%, P = .90). In combined 2020-2021 data, higher rates of burnout were associated with reported increased workload (Adjusted Odds Ratio (AOR) 1.38, 95% CI 1.19-1.6) and concerns regarding the effect of COVID on training (AOR 1.35, 95% CI 1.2-1.53). Program-level county COVID burden in combined 2020-2021 data was not associated with burnout in this model (AOR=1.03, 95% CI 0.70-1.52). CONCLUSIONS: Burnout rates within reporting programs decreased significantly in 2020 and returned to prepandemic levels in 2021. Increased burnout was associated with perceived increases in workload and concerns regarding effect of the pandemic on training. Given these findings, programs should consider further investigation into workload and training uncertainty on burnout.

Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit.

BACKGROUND: Preterm birth and resulting respiratory failure is a leading cause of newborn death- the majority of which occur in resource-constrained settings and could be prevented with bubble continuous positive airway pressure (bCPAP). Commercialized devices are expensive, however, and sites commonly use improvised devices utilizing 100% oxygen which can cause blindness. To address this, PATH and a multidisciplinary team developed a very low-cost bCPAP device including fixed-ratio oxygen blenders. OBJECTIVE: We assessed feasibility of use of the device on neonatal patients as well as the usability and acceptability of the device by healthcare workers. This study did not evaluate device effectiveness. METHODS: The study took place in a Ugandan level two unit. Neonates with respiratory failure were treated with the bCPAP device. Prospective data were collected through observation as well as likert-style scales and interviews with healthcare workers. Data were analyzed using frequencies, means and standard deviation and interviews via a descriptive coding method. Retrospectively registered via ClinicalTrials.gov number NCT05462509. RESULTS: Fourteen neonates were treated with the bCPAP device in October-December 2021. Patients were born onsite (57%), with median weight of 1.3 kg (IQR 1-1.8). Median treatment length was 2.5 days (IQR 2-6). bCPAP was stopped due to: improvement (83%) and death (17%). All patients experienced episodes of saturations >95%. Median time for device set up: 15 minutes (IQR 12-18) and changing the blender: 15 seconds (IQR 12-27). After initial device use, 9 out of 9 nurses report the set-up as well as blender use was "easy" and their overall satisfaction with the device was 8.5/10 (IQR 6.5-9.5). Interview themes included the appreciation for the ability to administer less than 100% oxygen, desire to continue use of the device, and a desire for additional blenders. CONCLUSIONS: In facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT05462509.

Implementation and Maturity of Clinical Learning Environment Components Across Pediatric Residency Programs.

OBJECTIVE: Pediatric residency programs prioritize clinical learning environment components depending on resource availability, institutional constraints and culture, and accreditation requirements. However, there is limited literature on the landscape of implementation and maturity of clinical learning environment components across programs nationally. METHODS: We used Nordquist's clinical learning environment conceptual framework to craft a survey around the implementation and maturity of learning environment components. We performed a cross-sectional survey of all pediatric program directors enrolled in the Pediatric Resident Burnout-Resiliency Study Consortium. RESULTS: Components with the highest implementation rates were resident retreats, in-person social events, and career development, while components least likely to be implemented were scribes, onsite childcare, and hidden curriculum topics. The most mature components were resident retreats, anonymous systems for reporting patient safety events, and faculty-resident mentoring programs, while the least mature components were use of scribes and formalized mentorship for trainees underrepresented in medicine. Learning environment components included in the Accreditation Council of Graduate Medical Education Program Requirements were significantly more likely to be implemented and mature than nonrequired components. CONCLUSIONS: To our knowledge, this is the first study to use an iterative and expert process to provide extensive and granular data about learning environment components for pediatric residencies.

Considering Risks to Researchers and Staff in Low-Resource Settings during Public Health Crises: A Proposed Conceptual Model.

Human subjects research protections have historically focused on mitigating risk of harm and promoting benefits for research participants. In many low-resource settings (LRS), complex and often severe challenges in daily living, poverty, geopolitical uprisings, sociopolitical, economic, and climate crises increase the burdens of even minimal risk research. While there has been important work to explore the scope of ethical responsibilities of researchers and research teams to respond to these wider challenges and hidden burdens in global health research, less attention has been given to the ethical dilemmas and risk experienced by frontline researcher staff as they perform research-related activities in LRS. Risks such as job insecurity, moral distress, infection, or physical harm can be exacerbated during public health crises, as recently highlighted by the COVID-19 pandemic. We highlight the layers of risk research staff face in LRS and present a conceptual model to characterize drivers of this risk, with particular attention to public health crises. A framework by which funders, institutions, principal investigators, and/or research team leaders can systematically consider these additional layers of risk to researchers and frontline staff is an important and needed addition to routine research proposals and protocol review.

Attitudes of healthcare providers towards non-initiation and withdrawal of neonatal resuscitation for preterm infants in Mongolia.

Antenatal parental counselling by healthcare providers is recommended to inform parents and assist with decision-making before the birth of a child with anticipated poor prognosis. In the setting of a low-income country, like Mongolia, attitudes of healthcare providers towards resuscitation of high-risk newborns are unknown. The purpose of this study was to examine the attitudes of healthcare providers regarding ethical decisions pertaining to non-initiation and withdrawal of neonatal resuscitation in Mongolia. A questionnaire on attitudes towards decision-making for non-initiation and withdrawal of neonatal resuscitation was administered to 113 healthcare providers attending neonatal resuscitation training courses in 2009 in Ulaanbaatar, the capital and the largest city of Mongolia where -40% of deliveries in the country occur. The questionnaire was developed in English and translated into Mongolian and included multiple choices and free-text responses. Participation was voluntary, and anonymity of the participants was strictly maintained. In total, 113 sets of questionnaire were completed by Mongolian healthcare providers, including neonatologists, paediatricians, neonatal and obstetrical nurses, and midwives, with 100% response rate. Ninety-six percent of respondents were women, with 73% of participants from Ulaanbaatar and 27% (all midwives) from the countryside. The majority (96%) of healthcare providers stated they attempt pre-delivery counselling to discuss potential poor outcomes when mothers present with preterm labour. However, most (90%) healthcare providers stated they feel uncomfortable discussing not initiating or withdrawing neonatal resuscitation for a baby born alive with little chance of survival. Religious beliefs and concerns about long-term pain for the baby were the most common reasons for not initiating neonatal resuscitation or withdrawing care for a baby born too premature or with congenital birth-defects. Most Mongolian healthcare providers provide antenatal counselling to parents regarding neonatal resuscitation. Additional research is needed to determine if the above-said difficulty with counselling stems from deficiencies in communication training and whether these same counselling-related issues exist in other countries. Future educational efforts in teaching neonatal resuscitation in Mongolia should incorporate culturally-sensitive training on antenatal counselling.

Respiratory distress syndrome management in resource limited settings-Current evidence and opportunities in 2022.

The complications of prematurity are the leading cause of neonatal mortality worldwide, with the highest burden in the low- and middle-income countries of South Asia and Sub-Saharan Africa. A major driver of this prematurity-related neonatal mortality is respiratory distress syndrome due to immature lungs and surfactant deficiency. The World Health Organization's Every Newborn Action Plan target is for 80% of districts to have resources available to care for small and sick newborns, including premature infants with respiratory distress syndrome. Evidence-based interventions for respiratory distress syndrome management exist for the peripartum, delivery and neonatal intensive care period- however, cost, resources, and infrastructure limit their availability in low- and middle-income countries. Existing research and implementation gaps include the safe use of antenatal corticosteroid in non-tertiary settings, establishing emergency transportation services from low to high level care facilities, optimized delivery room resuscitation, provision of affordable caffeine and surfactant as well as implementing non-traditional methods of surfactant administration. There is also a need to optimize affordable continuous positive airway pressure devices able to blend oxygen, provide humidity and deliver reliable pressure. If the high prematurity-related neonatal mortality experienced in low- and middle-income countries is to be mitigated, a concerted effort by researchers, implementers and policy developers is required to address these key modalities.

Risk factors for stillbirth and neonatal mortality among participants in Mobile WACh NEO pilot, a two-way SMS communication program in Kenya.

Globally, 2.5 million neonates die and 2 million more are stillborn each year; the vast majority occur where access to life-saving care is limited. High quality, feasible interventions are needed to reach, educate and empower pregnant women and new mothers to improve care-seeking behaviors. Mobile WACh (Mobile solutions for Women's and Children's health) NEO is a human-computer hybrid mobile health (mHealth) system that allows for two-way short message service (SMS) communication between women and healthcare workers during the peripartum period. We performed a secondary prospective cohort analysis of data from the Mobile WACh NEO pilot study to determine maternal characteristics associated with neonatal death and stillbirth and examine participant messaging associated with these events. Pregnant women were enrolled at two Kenyan public health clinics between 28-36 weeks gestation. They received personalized, educational, action-oriented SMS messages during pregnancy and through 14 weeks postpartum. Participants could message the study at any time and study nurses responded. Standardized questionnaires assessed participant characteristics at baseline and 14 weeks postpartum. Outcomes were ascertained at study visits or by SMS report. Among 798 pregnant women enrolled, median age was 24 years [IQR 21, 29], 37% were primiparous and 92% used SMS as a primary mode of communication. Seventeen neonatal deaths and 13 stillbirths occurred. Older maternal age was associated with increased risk of stillbirth [aRR 1.12 (CI 1.02-1.24), p <0.05]. We found no significant predictors of neonatal death. Participant messaging to study nurse about concerns in the week preceding death was less common prior to infant death after discharge home from facility birth (9%) than prior to stillbirth (23%). We found limited predictors of neonatal death and stillbirth, suggesting identifying women prenatally for targeted support may not be a feasible strategy. Scarce messaging from mothers whose neonates died may reflect difficulties identifying illness or rapid deterioration and needs to be better understood to design and test interventions for this high-risk period. Messaging prior to stillbirth, while at similar levels as other periods, does not appear to have an impact as most women do not experience identifiable signs or symptoms prior to the event.

Effect of a Novel Mindfulness Curriculum on Burnout During Pediatric Internship: A Cluster Randomized Clinical Trial.

IMPORTANCE: Mindfulness curricula can improve physician burnout, but implementation during residency presents challenges. OBJECTIVE: To examine whether a novel mindfulness curriculum implemented in the first 6 months of internship reduces burnout. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, multicenter, stratified cluster randomized clinical trial of a mindfulness curriculum randomized 340 pediatric interns to the intervention or control arm within program pairs generated based on program size and region. Fifteen US pediatric training programs participated from June 14, 2017, to February 28, 2019. INTERVENTIONS: The intervention included 7 hour-long sessions of a monthly mindfulness curriculum (Mindfulness Intervention for New Interns) and a monthly mindfulness refresher implemented during internship. The active control arm included monthly 1-hour social lunches. MAIN OUTCOMES AND MEASURES: The primary outcome was emotional exhaustion (EE) as measured by the Maslach Burnout Inventory 9-question EE subscale (range, 7-63; higher scores correspond to greater perceived burnout). Secondary outcomes were depersonalization, personal accomplishment, and burnout. The study assessed mindfulness with the Five Facet Mindfulness Questionnaire and empathy with the Interpersonal Reactivity Index subscales of perspective taking and empathetic concern. Surveys were implemented at baseline, month 6, and month 15. RESULTS: Of the 365 interns invited to participate, 340 (93.2%; 255 [75.0%] female; 51 [15.0%] 30 years or older) completed surveys at baseline; 273 (74.8%) also participated at month 6 and 195 (53.4%) at month 15. Participants included 194 (57.1%) in the Mindfulness Intervention for New Interns and 146 (42.9%) in the control arm. Analyses were adjusted for baseline outcome measures. Both arms' EE scores were higher at 6 and 15 months than at baseline, but EE did not significantly differ by arm in multivariable analyses (6 months: 35.4 vs 32.4; adjusted difference, 3.03; 95% CI, -0.14 to 6.21; 15 months: 33.8 vs 32.9; adjusted difference, 1.42; 95% CI, -2.42 to 5.27). None of the 6 secondary outcomes significantly differed by arm at month 6 or month 15. CONCLUSIONS AND RELEVANCE: A novel mindfulness curriculum did not significantly affect EE, burnout, empathy, or mindfulness immediately or 9 months after curriculum implementation. These findings diverge from prior nonrandomized studies of mindfulness interventions, emphasizing the importance of rigorous study design and suggesting that additional study is needed to develop evidence-based methods to reduce trainee burnout. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03148626.