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Title: Strategies for Successful Research Recruitment and Program Implementation in Pediatric Emergency Medicine (PEM)  
Authors:  Calamaro, Jacob G; Benedit, Laura; Abdallah, Calvin; Akinsola, Bolanle; Berkowtiz, Tal; Bora, Natoli; Burger, Rebecca K; Cameron, Melissa; Daniel, Jordan; Francois, Sandy; Grell, Robert; Griffiths, Mark; Gutierrez, Peter; Hatabah, Dunia; Hoyos, Ashley; Jain, Shabnam; Jones, Kaitlin; Kahn, Naghma;  Konatham, Sravani; Korman, Rawan; Ling, Jeffery; Little, Wendalyn; Luu, Vivian; McCloskey, Marc; Middlebrooks, Lauren; Ng, Carrie; Perez, Emily; Promer, Grace; Rees, Christopher A; Simon, Harold K; Wynn, Bridget; Morris, Claudia R 
 
Presented at:  Southeastern Pediatric Research Conference, Atlanta GA,  June 2024 (Poster Presentation)

Background:  Difficulties in performing research and program implementation in the emergency department (ED) setting are well documented in adult literature yet there is a paucity of information for pediatrics. Program implementation and clinical study recruitment in PEM is particularly difficult in a fast-paced environment treating sick and injured children. Understanding key strategies that assist in successful and timely research recruitment and program implementation in this setting is important.  
Objective:  To describe key strategies utilized by a PEM research team at an academic children’s hospital from January-December 2023.  
Methods:  We conducted a cross-sectional study examining research and implementation program staff opinions on key strategies for success in recruitment, study operations and program implementation. Thirty-two members of the PEM research team including research coordinators (RCs), managers, trainees/post-doctoral fellows and physician-investigators were asked to list key research strategies for success. Thirty-two initial strategies were identified and then themes were condensed into 18 items. Staff were then asked to complete an anonymous Qualtrix survey ranking the 18 items in order of importance. The top 10 choices were ranked in order of importance with weighted points (10-1 points for top 1-10 respectively); items were then ranked based on accumulated points determining top 10 strategies.  
Results:  Thirty responses were recorded, a 93% response rate. The top 3 weighted strategies were: 1. Boots on the ground presence of research team in the emergency department (ED), 2. Physician and ED Staff study education, and 3. Key leadership and institutional support.  Other top themes included use of technology, team communication, PEM staff incentives for research participation, and interdisciplinary collaboration. These and other strategies contributed to over 1500 patient enrollments into PEM research studies and >1880 patients into PEM implementation projects in 2023 at Children’s Healthcare of Atlanta.  
Discussion: Despite known challenges in PEM research and program implementation, multiple strategies can be employed to cultivate success. Specifically, boots on the ground enrollment with a diverse enthusiastic team, staff education, and various uses of technology for streamlined enrollment, have led to successful pediatric research and program implementation in the digital age with a focus on innovation, collaboration and translation.  

 

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Title: Improvement in functional outcomes in pediatric survivors of extracorporeal life support
Authors:  Meaghan A. Molloy, Michael P. Fundora, Jacob Calamaro, Cassidy Golden, Yijin Xiang, Joel Davis, RRT-NPS, Heather Viamonte
 
Presented at:  Keystone ECMO Conference, Colorado, January 2023 (Podium Presentation)
 
Introduction:  As extracorporeal life support (ECLS) survivorship has improved, research focus has shifted to emphasize medium and long-term outcomes, but few existing studies address this.  This study aims to describe the morbidity accrued during hospitalization for ECLS survivors.
Methods:  Single-center retrospective study of cardiac and pediatric non-cardiac patients requiring ECLS from March 2020 to October 2021. Patients with follow-up data within 12 months post-discharge were included. Demographics, ECLS variables, and serial functional status scores were collected. Functional status scores (FSS) are composed of six domains: mental status, sensory, communication, motor function, respiratory, and feeding with an FSS of 1 indicating ‘normal’ for each domain and 5 indicating ‘very severe dysfunction’.
Results:  Forty-two patients met inclusion criteria: 33% female, 93% VA ECMO, and 12% with single ventricle anatomy. Median age was 1.7 years [IQR 10 days-11.9 years]. Median hospital stay was 51 days [IQR 34-91 days] and median ECMO duration was 94 hours [IQR 56-142 hours]. The most commonly acquired new diagnoses among survivors were neurologic and included seizures and CNS ischemia/infarction. New morbidity (FSS change ≥3) occurred in 10 children (24%) from admission to discharge.  Children with new morbidity (FSS change ≥3) were more likely to be younger (p=0.01), have underlying genetic syndromes (p=0.02), and demonstrate evidence of neurologic injury by electroencephalogram (EEG) or diagnostic imaging (p=0.05). The mean FSS at discharge was 8.2 (SD ±2.6). The mean change in FSS from discharge to follow-up at 9 months (N=37) was -0.8 (95% CI -1.3 to -0.4, p < 0.001) and at 12 months (N=34) was -1 (95% CI -1.5 to -0.4, p < 0.001) with most improvement occurring in the feeding score.
Conclusion:  Survivors of ECLS endure significant morbidity accrual during their hospital stay with neurologic morbidity being the most common. Improvements in FSS (specifically the feeding score) occurred by the 12 month follow up. Further studies are imperative to elucidate modifiable factors that will improve long term outcomes in these patients.
 
 
Title: Vascular Ring Repair: A unique phenotype for post-operative chylothorax
Authors:  Stephanie P. Schwartz, MD; Melissa M. Winder APRN; Lawrence E. Greitan, MD; Alyssa N. Bautista, MD; Michael P. Fundora, MD; Bao N. Puente, MD; Sarah T. Plummer, MD; Rebecca A. Bertrandt, MD; Nathaniel R Sznycer-Taub, MD; Megan J Matiasek APRN; Kalpana S. Norbisrath, MD; Amy Lay, MD; Renee Milroy APRN; Jacob Calamaro; David K, Bailly, MD
 
Presented at:  PC4 Conference Dallas, Texas, May 2024 (Poster Presentation)
 
Introduction/Objective:  Chylothorax following pediatric cardiac surgery is a known complication associated with significant morbidity, mortality, and cost.  Postoperative chylothorax after vascular ring (VR) repair occurs in 2-12% of patients in published single center studies and may comprise a unique phenotype for chylous leak given a higher propensity for direct thoracic duct injury during the operation, as opposed to chylothorax caused by inflammation, elevated venous pressures, or abnormalities in the postoperative circulations.  The aim of this study is to describe characteristics and management strategies of patients with chylothorax following VR repair across multiple pediatric cardiac surgical centers, with a secondary aim of comparing these patients to a cohort of patients with chylothorax following any other cardiac surgery.
Methods:  Retrospective multicenter cohort study collecting data on all patients < 18 years old who developed chylothorax following VR repair at eight pediatric cardiac surgical institutions from 1/1/2021 – 12/31/2023.  Data was obtained from PC4 and PAC3, as well as additional data on chylothorax characteristics from a multicenter chylothorax workgroup (CWG) registry.  The CWG was created in November 2020 to improve clinical outcomes in pediatric patients with postoperative chylothorax. Comparisons were made to children within the CWG database who developed postoperative chylothorax following any other cardiac surgeries during the same time period. 
Results:  1,030 PAC3 and/or PC4 hospitalizations included VR repair between 1/1/2021-12/31/2023, with 131 (12.7%) developing postoperative chylothorax.  In the CWG, 44 patients had a chylothorax following VR repair during the study time period and 250 patients had chylothorax following any other cardiac surgery.  Compared to chylothorax following other cardiac surgeries, VR patients were diagnosed with chylothorax earlier (POD 1 vs POD 5, p<0.0001) and had shorter median total chest tube duration (4 days vs 11 days, p = 0.003).  A significantly higher percentage of VR chylothorax patients required secondary invasive intervention including thoracic duct ligation, embolization, or pleurodesis for the treatment of chylothorax (16% vs 5%, p=0.009), with 11% of VR chylothorax patients undergoing thoracic duct ligation vs 1% of all other postoperative chylothorax patients (p<0.0001).  Additionally, a trend towards earlier secondary invasive intervention in the VR chylothorax cohort was observed (median: 5 days after chylothorax diagnosis vs 10 days, p=0.18).
Conclusions:  Chylothorax following VR repair is a unique phenotype which likely reflects direct injury to the thoracic duct. In this subset of patients, secondary invasive intervention is more common, and may contribute to shorter chest tube duration. Early secondary invasive intervention may be more appropriate in these patients based on the mechanism of chylothorax. Further multicenter studies are needed to determine if treatment strategies tailored to different etiologies of postoperative chylothorax should be recommended. 


Title: Efficacy of Attenuating Analgesia and Sedation Requirements with Propofol in a Pediatric Cardiac Intensive Care Unit
Authors:  Zachary Barbara DO, Jacob Calamaro, Katie Liu MSPH, Hania Zaki PharmD, Marcos Mills MD, Nikhil K. Chanani MD, Michael P. Fundora MD 
 
Presented at:  World Federation of Pediatric Intensive & Critical Care Societies, Mexico, June 2024 (Poster Presentation)

Background/Aim:  The efficacy of using propofol to facilitate weaning sedatives among patients requiring high doses of benzodiazepines in the pediatric intensive care unit is unclear. We sought to evaluate the safety and utility of using propofol to reduce sedation requirements amongst pediatric patients in the cardiac intensive care unit (CICU)
Methods:  A retrospective study was conducted. Included were patients 0-21 years admitted to the CICU who received a propofol infusion for >6 hours. Analgosedation dosages were recorded in the 24 hours preceding and up to 48 hours after propofol infusion and analyzed via logistic regression. 
Results:  There were 44 patients (56% male, median age 15 months, 63% surgical). The median duration of propofol infusion was 20 hours (IQR 10-36), median dose 3.08 mg/kg/hr (IQR 2.26-4.49). There was a reduction in opioid and dexmedetomidine dosages but not benzodiazepines after propofol infusion. Opioid dose decreased for every 1 month increase in age at 24 hours (-0.06mg/kg, p=0.021) and 48 hours (-0.10mg/kg, p=0.017).  Dexmedetomidine dose decreased for every 1 month increase in age at 24 hours (-0.05mg/kg/hr, p=0.038) but not 48 hours (-0.03 mg/kg/hr, p=0.240). Median lactate while on propofol was 1.1 mmol/L (0.9-1.5). There were no incidences of propofol related infusion syndrome.
Conclusions:  Propofol use to reduce analgosedation has an age-related decrease in opioids. Dexmedetomidine dose requirements may also be affected by propofol attenuation. Further prospective studies are needed to evaluate the efficacy and safety of propofol use for analgosedation reduction. ​​​

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Intravenous Calcium Utilization in Neonates and Infants After Congenital Heart Surgery and Its Association With Outcomes: A Retrospective Multi-Institutional Exploratory Analysis Gurpreet S. Dhillon, MD1; Eleonore Valencia, MD2; Jacob Calamaro, BS; Kimberly Gauvreau, Sc.D2; Michael P. Fundora, MD4; Alan D. Schroeder, MD5; Marc D. Berg, MD5; Susan R. Hupp, MD4; David A. Axelrod, MD1; Ravi R. Thiagarajan, MD2, MPH; David M. Kwiatkowski, MD1​​

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Accepted: Pediatric Cardiac Intensive Care Society Annual Meeting, San Diego CA, November 2024 (Poster Presentation)​

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Objective: Intravenous calcium is utilized frequently in pediatric cardiovascular intensive care units (CVICU) for neonates and infants undergoing congenital heart surgery (CHS). Critical illness is associated with abnormal calcium handling, and induced hypercalcemia may carry adverse effects. We aimed to describe calcium utilization across three CVICUs, determine predictors of hypercalcemia and calcium administration, and evaluate their association with outcomes.

Design: Multicenter retrospective cohort analysis, 01/2020-12/2022

Setting: Three academically-affiliated pediatric CVICUs

Patients: Children < 6 months of age undergoing CHS who receive post-operative monitoring of ionized calcium (iCa) levels.

Interventions: None

Measurements: Average ionized calcium (iCa) for each 24-hour period were calculated from iCa values drawn for first 72 hours post-operatively (Normocalcemia: 1.2-1.4 millimoles/liter).

Main Results: Two-hundred seventy-six infants were evaluated, including 119 (43%) neonates, 44 (16%) with single ventricle physiology and 62 (23%) undergoing STAT 4 & 5 category surgery . Median age at surgery was 50 [7.3,113.5] days. Intravenous calcium administration differed among centers, with calcium administered in 21%, 62%,and 96% of cohorts (p<0.001) at respective hospitals. Hypercalcemia (compared to normocalcemia and hypocalcemia) was more prevalent in neonates, patients with longer CPB times, and higher postoperative vasoactive-inotrope scores. Hypercalcemia was associated with longer CVICU length of stay (LOS), mechanical ventilation days (MVD), and hospital LOS. Children in the top 10% of calcium administration (compared to those receiving some calcium and no calcium) were younger, experience higher rates of cardiac arrest, had longer CVICU LOS, and lower survival rates. In multivariable analysis, receiving in top 10% of calcium administration in first 48 hours was associated with longer MVD (p=0.002) and hospital LOS (p=0.02).

Conclusions: Postoperative calcium management in neonates/infants undergoing CHS varies significantly amongst CVICUs. Increased calcium administration and hypercalcemia occur in high-risk populations (e.g., neonates, STAT ≥4 surgery). Early post-operative aggressive calcium administration was associated with longer LOS and MVD.

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