A Pilot Randomized Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score (The PDA RCT).

OBJECTIVES: To evaluate the feasibility of recruiting preterm infants to a randomized controlled trial of patent ductus arteriosus (PDA) treatment based on a PDA severity score (PDAsc) and to characterize challenges in obtaining consent, compliance with the protocol, and PDA closure rates. STUDY DESIGN: This single-center, randomized control pilot study of 60 infants <29 weeks of gestation with a high PDAsc (≥5.0) at 36-48 hours of age receiving either ibuprofen or placebo intravenously. The study protocol did not allow for additional PDA therapy within the first 2 weeks. We reported the rate of consent, open label treatment, and PDA closure rates. The primary outcome was chronic lung disease or death. RESULTS: We approached 83 families for enrollment with 73 (88%) providing consent; 13 infants had a PDAsc of <5; of the remaining infants, 30 were assigned ibuprofen and 30 received placebo. Eight infants received open label treatment in the first 2 weeks (12%). The overall PDA closure rate after treatment was 57% in the intervention group and 17% in the control group (P < .01). There was no difference in the primary clinical outcome (OR, 0.8; 95% CI, 0.3-2.1). CONCLUSIONS: Using a PDAsc for infant recruitment to a PDA treatment randomized controlled trial is feasible. There is a high rate of consent and relatively low rate of open-label PDA treatment. The overall PDA closure rate in the intervention arm was low placing the emphasis on devising more effective PDA closure strategies in future randomized controlled trials. TRIAL REGISTRATION: ISRCTN (13281214) and European Union Drug Regulating Authorities Clinical Trials Database (2015-004526-33).

Identification of Prescribing Errors in an Electronic Health Record Using a Retract-and-Reorder Tool: A Pilot Study.

OBJECTIVES: The aims of this study were to develop and to validate an adapted Retract-and-Reorder (RAR) tool to identify and quantify near-miss/intercepted prescribing errors in an electronic health record. METHODS: This is a cross-sectional study between February and March 2021 in an Irish maternity hospital. We used the RAR tool to detect near-miss prescribing errors in audit log data. Potential errors flagged by the tool were validated using prescriber interviews. Chart reviews were performed if the prescriber was unavailable for interview. Errors were judged to be clinical decisions in chart reviews through review of narrative notes, order components, and patient's clinical history. Interviews were analyzed with reference to the London Protocol, a process of incident analysis that categorizes causes of errors into various contributory factors including patient factors, task and technology factors, and work environment. Logistic regression with robust clustered standard errors was used to determine predictors for near-miss prescribing errors. We calculated the positive predictive value of the RAR tool by dividing the number of confirmed near-miss prescribing errors by the total number of RAR events identified. RESULTS: Eighty-four RAR events were identified in 27,407 medication orders. Seventy-one events were confirmed near-miss prescribing errors, resulting in a positive predictive value of 85.0% (95% confidence interval, 75%-91%) and an estimated near-miss prescribing error rate of 259/100,000 medication orders. Duplicate prescribing errors were most common (54/71, 76.1%). No errors were reported by prescribers. Consultants were less likely to make an error than nonconsultant hospital doctors (adjusted odds ratio, 0.10; 95% confidence interval, 0.01-0.84). Factors associated with errors included workload, staffing levels, and task structure. CONCLUSIONS: Our adapted RAR tool identified a variety of near-miss prescribing errors not otherwise reported. The tool has been implemented in the study hospital as a patient safety resource. Further implementations are planned across Irish hospitals.

Early targeted patent ductus arteriosus treatment in premature neonates using a risk based severity score: study protocol for a randomised controlled trial (PDA RCT).

A patent ductus arteriosus (PDA) in preterm infants is associated with increased ventilator dependence and chronic lung disease, necrotizing enterocolitis, intraventricular haemorrhage, and poor neurodevelopmental outcome. Randomised controlled trials of early PDA treatment have not established a drop in the aforementioned morbidities. Those trials did not physiologically categorise PDA severity. Incorporating the specific physiological features of a haemodynamic significant PDA may evolve our understanding of this phenomenon, allowing accurate triaging using echocardiography and targeted treatment.  Our group has recently demonstrated that a PDA severity score (PDAsc) derived at 36-48 hours of age can accurately predict the later occurrence of chronic lung disease or death (CLD/Death). Using echocardiography, we assessed PDA characteristics, as well as left ventricular diastolic function and markers of pulmonary overcirculation, and from this formulated a PDAsc. Gestation was also incorporated into the score. We hypothesise that in preterm infants at high risk of developing CLD/Death based on a PDAsc, early treatment with Ibuprofen compared with placebo will result in a reduction in CLD/Death. This is a single centre double-blind two arm randomised controlled trial conducted in the neonatal intensive care unit in the Rotunda Hospital, Dublin. Echocardiogram is carried out in the first 36-48 hours of life to identify preterm infants with a PDAsc ≥ 5.0 and these infants are randomised to Ibuprofen or placebo. Primary outcomes are assessed at 36 weeks post menstrual age. This pilot study's purpose is to assess the feasibility of performing the trial and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of early PDA treatment using a PDAsc. We aim to recruit a total of 60 infants with a high risk PDA over three years. Trial Registration: ISRCTN ISRCTN13281214 (26/07/2016) and the European Union Drug Regulating Authorities Clinical Trials Database 2015-004526-33 (03/12/2015).