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Outcomes in Neonates Receiving Therapeutic Hypothermia and Extracorporeal Membrane Oxygenation versus Extracorporeal Membrane Oxygenation Alone

Cicalese, Erin; Seltzer, Bryn H S; Fisher, Jason C; Verma, Sourabh
OBJECTIVE:To examine survival and outcomes in neonates who received therapeutic hypothermia (TH) for neonatal encephalopathy (NE) and extracorporeal membrane oxygenation (ECMO) versus ECMO alone. STUDY DESIGN/METHODS:This is a retrospective review of Extracorporeal Life Support Organization (ELSO) Registry data from 2007 to 2017 for neonates undergoing ECMO and TH for NE (TH/ECMO) or ECMO alone. Primary outcomes were ECMO survival and survival to discharge. Secondary outcomes were complications while on ECMO. Statistical analysis was performed using Fisher's Exact and Mann-Whitney U testing. Multivariate regression was performed to identify predictors of ECMO survival. RESULTS:Of 3 672 neonates, 215 (6%) received TH/ECMO, while 3 457 (94%) received ECMO alone. There was no significant difference in ECMO survival (92% vs. 92%, P=0.70) or survival to discharge (87% vs. 85%, P=0.43) between groups. TH/ECMO group had higher hemorrhagic (29% vs. 20%, P<0.01), neurologic (24% vs.12%, P<0.01) , and metabolic (28% vs. 15%, p<0.01) complications. Multivariate regression identified higher gestational age, absence of inotropes during ECMO, and lack of neurologic, pulmonary, or hemorrhagic complications as independent predictors of ECMO survival. CONCLUSION/CONCLUSIONS:Neonates undergoing ECMO and TH for NE had survival rates comparable to those receiving ECMO alone. These findings suggest that ECMO can be considered for neonates with NE undergoing TH who meet criteria for ECMO.
PMID: 39662895
ISSN: 1098-8785
CID: 5762762

Developing a new pediatric extracorporeal membrane oxygenation (ECMO) program

Cicalese, Erin; Meisler, Sarah; Kitchin, Michael; Zhang, Margaret; Verma, Sourabh; Dapul, Heda; McKinstry, Jaclyn; Toy, Bridget; Chopra, Arun; Fisher, Jason C
OBJECTIVES/OBJECTIVE:We aimed to critically evaluate the effectiveness of a designated ECMO team in our ECMO selection process and patient outcomes in the first 3 years of our low-volume pediatric ECMO program. METHODS:We conducted a retrospective chart review of patients who received an ECMO consultation between the start of our program in March 2015 and May 2018. We gathered clinical and demographic information on patients who did and did not receive ECMO, and described our selection process. We reflected on the processes used to initiate our program and our outcomes in the first 3 years. RESULTS:, lactate, and pH between the patients who went on ECMO and who did not. We improved our outcomes from 0% survival to discharge in 2015, to 60% in 2018, with an average of 63% survival to discharge over the first 3 years of our program. CONCLUSIONS:In a low-volume pediatric ECMO center, having a designated team to assist in the patient selection process and management can help provide safe and efficient care to these patients, and improve patient outcomes. Having a strict management protocol and simulation sessions involving all members of the medical team yields comfort for the providers and optimal care for patients. This study describes our novel structure, processes, and outcomes, which we hope will be helpful to others seeking to develop a new pediatric ECMO program.
PMID: 36508606
ISSN: 1619-3997
CID: 5381932

Visitor restriction during the COVID-19 pandemic did not impact rates of Staphylococcus aureus colonization in the NICU patients

Evans, Hailey Zie; Bailey, Sean; Verma, Sourabh; Cicalese, Erin
OBJECTIVES/OBJECTIVE:colonization rates before and after the visitor policy change, which coincided with the exponential rise of COVID-19 cases in New York City (NYC). METHODS:colonization. RESULTS:=0.02). CONCLUSIONS:colonization rate. Hospital unit leaders may need to focus on other strategies in order to reduce colonization.
PMID: 36190160
ISSN: 1619-3997
CID: 5351352

Essentials of Neonatal-Perinatal Medicine fellowship: part 2 - clinical education and experience

Cicalese, Erin; Wraight, C Lydia; Falck, Alison J; Izatt, Susan D; Nair, Jayasree; Lawrence, Karena G
This is the second article in a seven-part series in the Journal of Perinatology that aims to critically examine the current state of Neonatal-Perinatal Medicine (NPM) fellowship training from the structure and administration of a program, to the clinical and scholarly requirements, and finally to the innovations and future careers awaiting successful graduates. This article focuses on the current clinical requirements; recent changes to the clinical environment and their effect on learning; and additional challenges and opportunities in clinical education.
PMID: 33850281
ISSN: 1476-5543
CID: 4889582

Implementation of Pediatric ECMO Safety Rounds for Real-time Quality Improvement [Meeting Abstract]

Toy, B; Beaulieu, T; LoRe, K; Cicalese, E; Dapul, H; Maldonado, M; McKinstry, J; Verma, S; Chopra, A; Fisher, J C
Study: Our Pediatric ECMO Program implemented ECMO Safety Rounds (ESR) as a quality improvement (QI) initiative. Objectives were to ensure implementation of protocols, immediately correct quality/safety deficiencies, and provide real-time education to nurses and perfusionists. Our specific aim was to track compliance with this process-improvement bundle and identify areas to target with QI efforts, with a long-term global aim of reducing quality/safety variances and patient harm over time. XXMethod(s): Our team initiated Pediatric ESR in September 2019. Two process- based QI bundles were developed: (1) Circuit Safety - 35 bundle elements, including maintenance and emergency checks; (2) Patient Safety - 13 bundle elements focused on nursing practices specific to minimizing patient harm. Pediatric ESR consisted of these two bundle assessments performed by designated ESR clinicians at the bedside with the patient's nurse and perfusionist. Credit for bundle compliance was awarded only if all elements were properly met. Noncompliant elements were addressed in real-time. All data was recorded in REDCap database. XXResult(s): 36 Pediatric ESRs were completed (Sept. 2019 - Jan. 2021). Monthly bundle compliance was reported using run charts. Median compliance with both bundles appeared to improve over time, with their most recent centerlines both at 67% compliance (Figure 1). Analysis of individual bundle elements revealed that 19/48 (40%) safety items were deficient at least once during the 36 ESRs (Table 1). Any individual bundle element with greater than 2 noncompliance events prompted our team to target interventions addressing these lapses, including new protocols and education, conducting multidisciplinary reviews, and collaborating with ancillary departments. We conclude that Pediatric ESR provides real-time assessment of compliance, immediate corrective and education measures, and actionable data to drive performance improvement around observed vulnerabilities in ECMO protocols
EMBASE:635362843
ISSN: 1538-943x
CID: 4929602

Morbidity of conversion from venovenous to venoarterial ECMO in neonates with meconium aspiration or persistent pulmonary hypertension

Choi, Beatrix Hyemin; Verma, Sourabh; Cicalese, Erin; Dapul, Heda; Toy, Bridget; Chopra, Arun; Fisher, Jason C
BACKGROUND:Outcomes in neonates receiving extracorporeal membrane oxygenation (ECMO) for meconium aspiration syndrome (MAS) and/or persistent pulmonary hypertension (PPHN) are favorable. Infants with preserved perfusion are often offered venovenous (VV) support to spare morbidities of venoarterial (VA) ECMO. Worsening perfusion or circuit complications can prompt conversion from VV-to-VA support. We examined whether outcomes in infants requiring VA ECMO for MAS/PPHN differed if they underwent VA support initially versus converting to VA after a VV trial, and what factors predicted conversion. METHODS:We reviewed the Extracorporeal Life Support Organization registry from 2007 to 2017 for neonates with primary diagnoses of MAS/PPHN. Propensity score analysis matched VA single-runs (controls) 4:1 against VV-to-VA conversions based on age, pre-ECMO pH, and precannulation arrests. Primary outcomes were complications and survival. Data were analyzed using Mann-Whitney U and Fisher's exact testing. Multivariate regression identified independent predictors of conversion for VV patients. RESULTS:3831 neonates underwent ECMO for MAS/PPHN, including 2129 (55%) initially requiring VA support. Of 1702 patients placed on VV ECMO, 98 (5.8%) required VV-to-VA conversion. Compared with 364 propensity-matched isolated VA controls, conversion runs were longer (190 vs. 127 h, P < 0.001), were associated with more complications, and decreased survival to discharge (70% vs. 83%, P = 0.01). On multivariate regression, conversion was more likely if neonates on VV ECMO did not receive surfactant (OR = 1.7;95%CI = 1.1-2.7;P = 0.03) or required high-frequency ventilation (OR = 1.9;95%CI = 1.2-3.3;P = 0.01) before ECMO. CONCLUSION/CONCLUSIONS:Conversion from VV-to-VA ECMO in infants with MAS/PPHN conveys increased morbidity and mortality compared to similar patients placed initially onto VA ECMO. VV patients not receiving surfactant or requiring high-frequency ventilation before cannulation may have increased risk of conversion. While conversions remain rare, decisions to offer VV ECMO for MAS/PPHN must be informed by inferior outcomes observed should conversion be required. LEVEL OF EVIDENCE/METHODS:Level of evidence 3 Retrospective comparative study.
PMID: 33645507
ISSN: 1531-5037
CID: 4800052

Outcomes of Maternal-Newborn Dyads After Maternal SARS-CoV-2

Verma, Sourabh; Bradshaw, Chanda; Auyeung, N S Freda; Lumba, Rishi; Farkas, Jonathan S; Sweeney, Nicole B; Wachtel, Elena V; Bailey, Sean M; Noor, Asif; Kunjumon, Bgee; Cicalese, Erin; Hate, Rahul; Lighter, Jennifer L; Alessi, Samantha; Schweizer, William E; Hanna, Nazeeh; Roman, Ashley S; Dreyer, Benard; Mally, Pradeep V
PMID: 32737153
ISSN: 1098-4275
CID: 4553402

Group B streptococcal transmission rates as determined by PCR

Cicalese, Erin; Lamousé-Smith, Esi; Randis, Tara M; Ratner, Adam J
Background Group B Streptococcus (GBS) is a common cause of neonatal sepsis. GBS colonization of the newborn gastrointestinal tract (GIT) may be a critical precursor for late-onset infection. Assessment of the rate of neonatal GBS intestinal colonization has generally relied upon culture-based methods. We used polymerase chain reaction (PCR) and culture to determine the rate of GBS transmission to neonates. We hypothesized that PCR may enhance the detection of neonatal GBS colonization of the GIT, and that the rate will be higher when evaluated with PCR as compared to culture. Methods This was a cross-sectional study, in which mothers who were positive for GBS on routine screening and their healthy infants were eligible for recruitment. Newborn stool was collected after 24 h of life and before hospital discharge, and stored at -80°C for culture and PCR targeting the GBS-specific surface immunogenic protein (sip) gene. Results A total of 94 mother-infant pairs were enrolled; of these pairs, stool was collected from 83 infants. Based on PCR, the overall GBS transmission rate was 3.6% (3/83). The transmission rate was 2.4% (1/41) among vaginal deliveries and 4.8% (2/42) among cesarean deliveries. The results of culture-based transmission detection were identical. Conclusion These results indicate that the rate of GBS transmission is low and that detection may not be enhanced by PCR methods.
PMID: 32305955
ISSN: 1619-3997
CID: 4396722

Morbidity and mortality in early term infants with meconium aspiration and/or persistent pulmonary hypertension of newborn requiring ecmo [Meeting Abstract]

Verma, S; Choi, B H; Toy, B; Cicalese, E; Dapul, H; Chopra, A; Fisher, J
Infants with meconium aspiration syndrome (MAS) and/or persistent pulmonary hypertension of newborn (PPHN) have the most favorable outcomes among infants requiring extracorporeal membrane oxygenation (ECMO). Early term (ET) infants have been shown to have higher morbidities when compared with term infants. It is not known if ET infants requiring ECMO for MAS and/or PPHN have higher morbidities and mortality than term infants. Objective of our study was to compare morbidity and mortality in ET infants with MAS and/or PPHN requiring ECMO in comparison to their term counterparts. A total of 3831 neonatal ECMO runs for MAS and/or PPHN were reviewed from the de-identified ELSO registry patient dataset from 2007- 2017. Neonates born at ET (37+0/7 - 38+6/7 weeks) and term (39+0/7 - 40+6/7 weeks) were further classified as two study groups. Both groups were compared using chi-square test. Of 2529 infants who were included in the study, there were 799 ET and 1730 term infants. ET infants when compared with term infants had higher mortality (9.6% vs 6%, P=0.002), lower survival to discharge (80.4% vs 87.7%, P<0.001), higher neurologic complications (14.8% vs 11.5%, P=0.024), and increased need for hemofiltration (32.9% vs 28.7%, P=0.033). There were no statistically significant differences between both groups in hemorrhagic, infectious, metabolic and cardiovascular complications. ET infants with MAS and/or PPHN have higher morbidities and mortality than term infants on ECMO. Caregivers should be informed of higher risks associated with use of ECMO in ET infants when compared to full term newborns
EMBASE:631095453
ISSN: 1538-943x
CID: 4387232

Minimizing ECMO mobilization time for beside ECMO cannulations by maximizing multidisciplinary team efficiency [Meeting Abstract]

Toy, B; Cicalese, E; Dapul, H; Verma, S; Chopra, A; Fisher, J
The majority of neonatal and pediatric patients require emergent cannulations at the bedside in the intensive care unit (ICU). To accomplish a bedside cannulation, multidisciplinary teams need to work together and perform tasks that may be different from the usual practices in the ICU. The complexity of the many tasks that need to be completed can lead to significant delay if not well choreographed. Our project goal was to streamline the pre-cannulation process to decrease the time from ECMO mobilization to procedure start. The initiative was implemented in September 2016. Interventions included formalization of ECMO Program policies & procedures and multidisciplinary education, as well as implementation of formal patient case reviews & quality assurance meetings. Our team collaborated with ancillary departments to ensure timeliness and efficiency with orders & processes related to ECMO initiation. We also created a detailed precannulation checklist which defines each team members' role and their responsibilities in the pre-cannulation process. The checklist is reviewed prior to the procedure time out as a final check to ensure all required tasks are completed. Upon retrospective chart review, the pre- & post-initiative data revealed a 54% decrease in time from ECMO mobilization to cannulation procedure start. The post-initiative average time of 65 minutes showed successful improvement from the pre-initiative average time of 136 minutes. We concluded that a structured process for pre-cannulation preparedness, role definition, multidisciplinary education, and team debriefs maximize efficiency in team readiness for a bedside ECMO cannulation procedure
EMBASE:631095442
ISSN: 1538-943x
CID: 4387252