213 - Effectiveness and Safety of Acetaminophen for Patent Ductus Arteriosus Treatment in Extremely Low Gestational Age Neonates: A Retrospective Cohort Study
Sunday, April 30, 2023
3:30 PM – 6:00 PM ET
Poster Number: 213 Publication Number: 213.329
Bonny Jasani, The Hospital for Sick Children, Toronto, ON, Canada; George Jacob, University of Toronto Temerty Faculty of Medicine, Hamilton, ON, Canada; Macarena Garcia Gozalo, University of Toronto Temerty Faculty of Medicine, Toronto, ON, Canada; Jejelola Ladele, University of Toronto Temerty Faculty of Medicine, Toronto, ON, Canada; Eman Hashim, The Hospital for Sick Children, Toronto, ON, Canada; Gonzalo Solis-Garcia, THE HOSPITAL FOR SICK CHILDREN, TORONTO, ON, Canada; Amish Jain, University of Toronto Temerty Faculty of Medicine, toronto, ON, Canada; Dany Weisz, University of Toronto Temerty Faculty of Medicine, Toronto, ON, Canada
Staff Neonatologist The Hospital for Sick Children Toronto, Ontario, Canada
Background: Pooled analyses from randomized trials have shown that acetaminophen has similar efficacy and a superior safety profile compared with ibuprofen or indomethacin for patent ductus arteriosus (PDA) treatment among preterm infants. However, there is paucity of data for its effectiveness and safety among extremely low gestational age neonates (ELGANs: < 276/7 weeks gestation’ at birth). Objective: To evaluate the effectiveness and safety of acetaminophen for PDA treatment in ELGANs and identify predictors of treatment success. Design/Methods: We conducted a retrospective cohort study of ELGANs who were treated with acetaminophen (15mg/kg/dose every 6 hours for 3-7 days) for moderate to large persistent PDA across 3 level III neonatal intensive care units between June 1, 2012, to May 31st 2020. Infants who received < 12 doses of acetaminophen were excluded. Patient demographics, PDA characteristics on echocardiography, treatment details and outcomes were examined. Primary outcome was treatment success, defined >25% reduction in PDA diameter and no further need for PDA treatment (pharmacological or surgical). Secondary outcomes included complete PDA closure, adverse effects [hepatotoxicity, defined as ALT >100 units/litre requiring treatment, doubling of direct fraction of serum bilirubin from baseline, or gastrointestinal bleeding]. Multivariable logistic regression analysis was used to identify predictors of successful PDA treatment with acetaminophen. Results: Two-hundred and seventy-three ELGANs with PDA received acetaminophen over the 8-year period. The baseline characteristics and outcomes of included infants are shown in Table 1 and 2. Overall treatment effectiveness was 33% (91/273), while the rate of complete ductal closure was only 7.7% (21/273). No significant adverse safety events occurred, though there was a significant change noted in ALT after treatment (Table 2). Neither route of administration nor duration of treatment (3 vs 5 vs 7 days) was associated with increased effectiveness of acetaminophen treatment (Table 2). After adjusted analysis, higher birth weight was associated with increased odds of treatment success with acetaminophen (aOR 1.18; 95% CI 1.01 to 1.38, per 100g increment in birth weight).
Conclusion(s): Among ELGANs, treatment of moderate-to-large persistent PDA with acetaminophen was safe but had marginal effectiveness that was similar across route of administration and duration of treatment. Â Future comparative trials should focus on ELGANs with emphasis on developing more efficacious treatment regimes in this high-risk patient population.
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