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Introduction: Drug-related problems (DRPs) incidence is higher in neonatal intensive care units (NICUs), compared to other pediatric wards due to aspects like off-label medications, pharmacokinetic/dynamic variability, or organ dysfunction/immaturity. This study aimed to determine whether and to what extent a clinical pharmacist intervention improves medication safety and prevents DRPs [medication errors (MEs), adverse drug reactions (ADRs), drug-drug interactions (DDIs)]. Methods: A prospective, randomized, double blind, controlled study in NICU-admitted neonates was conducted. NICU patients were randomly assigned to the intervention (clinical pharmacist-led) (IG) or control group (standard care such as clinical diagnosis, pharmacotherapy) (CG). The clinical pharmacist was involved in the IG to identify-prevent-intervene MEs, or identify and monitor ADRs and DDIs. The primary outcome was the number of neonates who developed at least one DRP compared with those seen across IG and CG. Secondary outcomes included length of hospital stay, total number of drugs or DRP type. Results: Neonates were randomly assigned to CG (n = 52) or IG (n = 48). In total, 45%, 42%, and 16% of patients had at least 1 MEs, ADRs, and clinically significant DDIs, respectively. The number of patients with at least 1 ME was 28 (53%) and 17 (35%) in the CG and IG (p>0.05). The median (range) number of ME was higher in CG [1 (0–7)] than in IG [0 (0–4)] (p = 0.003). Applying regression analysis, the CG had 2.849 times more MEs than the IG (p<0.001). Furthermore, the number of patients (CG to IG) with at least one detected ADR or clinical DDI was 19 (36%) to 23 (47%) (p>0.05) and 4 (7%) to 12 (25%), respectively (p = 0.028). Conclusion: Clinical pharmacist availability to systematically and standardized identify, prevent and resolve DRPs among NICU patients is effective. Daily detailed clinical pharmacist obse

Aim: To develop models that predict the presence of medication errors (MEs) (prescription, preparation, administration, and monitoring) using machine learning in NICU patients. Design: Prospective, observational cohort study randomized with machine learning (ML) algorithms. Setting: A 22-bed capacity NICU in Ankara, Turkey, between February 2020 and July 2021. Results: A total of 11,908 medication orders (28.9 orders/patient) for 412 NICU patients (5.53 drugs/patient/day) who received 2,280 prescriptions over 32,925 patient days were analyzed. At least one physician-related ME and nurse-related ME were found in 174 (42.2%) and 235 (57.0%) of the patients, respectively. The parameters that had the highest correlation with ME occurrence and subsequently included in the model were: total number of drugs, anti-infective drugs, nervous system drugs, 5-min APGAR score, postnatal age, alimentary tract and metabolism drugs, and respiratory system drugs as patient-related parameters, and weekly working hours of nurses, weekly working hours of physicians, and number of nurses’ monthly shifts as care provider-related parameters. The obtained model showed high performance to predict ME (AUC: 0.920; 95% CI: 0.876–0.970) presence and is accessible online (http://softmed.hacettepe.edu.tr/NEO-DEER_Medication_Error/). Conclusion: This is the first developed and validated model to predict the presence of ME using work environment and pharmacotherapy parameters with high-performance ML algorithms in NICU patients. This approach and the current model hold the promise of implementation of targeted/precision screening to prevent MEs in neonates. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT04899960.

Article; Early Access, Objective Understanding the reflections of prematurity is necessary for the management of neonatal complications. We focused on the impact of prematurity and related maternal risk factors/obstetric complications on buccal cells of the neonates via evaluation of the Wnt/beta-catenin signaling pathway and apoptosis. Study Design This study consisted of early preterm neonates (EPN) (= 34th gestational week [gw]) (n = 36), late preterm neonates (LPN) (34th- 37th gw) (n = 46), and term neonates (control) (>= 37th gw) (n = 56). Cohort was also subclassified according to the presence of maternal risk factors, obstetric complications, and neonatal complications. Wnt/beta-catenin signaling and caspase-3 activation pathways were studied immunocytochemically. Results Wnt/beta-catenin signaling positivity was statistically more frequent at buccal smears of the EPN and LPN groups compared with controls (p0.001). The cutoff for gestational age at delivery in receiver operating characteristic curve with the best balance of sensitivity (67.4%) and specificity (67.3%) was 35.8th gw for determining the reduction of Wnt/beta-catenin signaling positivity (p 0.001). The study demonstrated that obstetric complications significantly affected the activity of signaling, while maternal risk factors do not have any effect on Wnt/beta-catenin signaling pathway (p = 0.003 and p = 0.828, respectively). This study also demonstrated a significant relationship between Wnt/beta-catenin signaling pathway and the presence of neonatal complications (p = 0.015). Conclusion Dynamic characteristics of buccal cells are influenced by prematurity and related obstetric and neonatal problems. Buccal smear is a good tool to investigate the impact of prematurity and obstetric problems on perinatal outcome., Hacettepe University Scientific Research Projects Coordination UnitHacettepe University [THD-2018-17493], This study was funded by Hacettepe University Scientific Research Projects Coordination Unit, Project number: THD-2018-17493.

Article; Early Access, Objective Understanding the reflections of prematurity is necessary for the management of neonatal complications. We focused on the impact of prematurity and related maternal risk factors/obstetric complications on buccal cells of the neonates via evaluation of the Wnt/beta-catenin signaling pathway and apoptosis. Study Design This study consisted of early preterm neonates (EPN) (= 34th gestational week [gw]) (n = 36), late preterm neonates (LPN) (34th- 37th gw) (n = 46), and term neonates (control) (>= 37th gw) (n = 56). Cohort was also subclassified according to the presence of maternal risk factors, obstetric complications, and neonatal complications. Wnt/beta-catenin signaling and caspase-3 activation pathways were studied immunocytochemically. Results Wnt/beta-catenin signaling positivity was statistically more frequent at buccal smears of the EPN and LPN groups compared with controls (p0.001). The cutoff for gestational age at delivery in receiver operating characteristic curve with the best balance of sensitivity (67.4%) and specificity (67.3%) was 35.8th gw for determining the reduction of Wnt/beta-catenin signaling positivity (p 0.001). The study demonstrated that obstetric complications significantly affected the activity of signaling, while maternal risk factors do not have any effect on Wnt/beta-catenin signaling pathway (p = 0.003 and p = 0.828, respectively). This study also demonstrated a significant relationship between Wnt/beta-catenin signaling pathway and the presence of neonatal complications (p = 0.015). Conclusion Dynamic characteristics of buccal cells are influenced by prematurity and related obstetric and neonatal problems. Buccal smear is a good tool to investigate the impact of prematurity and obstetric problems on perinatal outcome., Hacettepe University Scientific Research Projects Coordination UnitHacettepe University [THD-2018-17493], This study was funded by Hacettepe University Scientific Research Projects Coordination Unit, Project number: THD-2018-17493.

Background: Critically ill neonates are at greater risk for adverse drug reactions (ADRs). The differentiation of ADRs from reactions associated with organ dysfunction/immaturity or genetic variability is difficult. Methods: In this prospective cohort study, each ADR was assessed using newborn-specific severity and probability scales by the clinical pharmacist. Subsequently, a machine learning-based risk score was designed to predict ADR presence in neonates. Results: In 98/412 (23.8%) of (56.3%; male) neonates included, 187 ADRs (0.42 ADR/patient) were determined related to 49 different drugs (37.12%). Drugs identified as high risk were enoxaparin, dexmedetomidine, vinblastine, dornase alfa, etoposide/carboplatin and prednisolone. The independent variables included in the risk score to predict ADR presence, according to the random forest importance criterion, were: systemic hormones (2 points), cardiovascular drugs (3 points), diseases of the circulatory system (1 point), nervous system drugs (1 point), and parenteral nutrition treatment (1 point), (cut-off value: 3 points). This risk score correctly classified 91.1% of the observations in the test set (c-index: 0.914). Conclusions: Using the high-performing risk score specific to neonates, it is expected that high-risk neonatal ADRs can be determined and prevented before they occur. Moreover, the awareness of clinicians of these drugs can be improved with this web-tool, and mitigation strategies (change of drug, dose, treatment duration, etc.) can be considered, based on a benefit-harm relationship for suspected drugs with a newborn-centered approach.

Aims: Evidence for drug–drug interactions (DDIs) that may cause age-dependent differences in the incidence and severity of adverse drug reactions (ADRs) in newborns is sparse. We aimed to develop machine learning (ML) algorithms that predict DDI presence by integrating each DDI, which is objectively evaluated with the scales in a risk matrix (probability + severity). Methods: This double-center, prospective randomized cohort study included neonates admitted to the neonatal intensive care unit in a tertiary referral hospital during the 17-month study period. Drugs were classified by the Anatomical Therapeutic Chemical (ATC) classification and assessed for potential and clinically relevant DDIs to risk analyses with the Drug Interaction Probability Scale (DIPS, causal probability) and the Lexicomp® DDI (severity) database. Results: A total of 412 neonates (median (interquartile range) gestational age of 37 (4) weeks) were included with 32,925 patient days, 131 different medications, and 11,908 medication orders. Overall, at least one potential DDI was observed in 125 (30.4%) of the patients (2.6 potential DDI/patient). A total of 38 of these 125 patients had clinically relevant DDIs causing adverse drug reactions (2.0 clinical DDI/patient). The vast majority of these DDIs (90.66%) were assessed to be at moderate risk. The performance of the ML algorithms that predicts of the presence of relevant DDI was as follows: accuracy 0.944 (95% CI 0.888–0.972), sensitivity 0.892 (95% CI 0.769–0.962), F1 score 0.904, and AUC 0.929 (95% CI 0.874–0.983). Conclusions: In clinical practice, it is expected that optimization in treatment can be achieved with the implementation of this high-performance web tool, created to predict DDIs before they occur with a newborn-centered approach.

Objective To demonstrate the impact of preterm birth on the cytological, cytomorphometrical, and nuclear parameters of neonatal buccal smears. Methods This study consisted of Early Preterm Neonates (EPN; = 34th gestational week [gw]; n = 36), Late Preterm Neonates (LPN; 34th to 37th gw; n = 46), and Term Neonates (control; >= 37th gw; n = 56). Cytological evaluation and buccal cytome assay were performed using Papanicolaou and Feulgen methods, respectively. Results Cytological evaluation demonstrated that smear background was cleaner (P .05) and there were less macrophages in the control group (P .001). Cyto-morphometric analysis showed that the measurements of nuclear diameter, nuclear area, and nucleus-to-cytoplasm ratio were higher in the preterm (EPN and LPN) versus the control groups (P = .016, P .001, and P .001, respectively). We also demonstrated that staining intensity of the nucleus and cytoplasm were less intense in the EPN and LPN groups (P .001). There was no statistically significant difference between the EPN and LPN groups for any parameters (P > .05). Buccal cytome assay showed that nuclear buds were more prevalent in term newborns compared to preterm neonates (P .001). Conclusions Morphological and cytological properties of neonatal buccal cells are influenced by preterm birth status, and buccal smears may be used as a tool to detect biological markers of neonatal health problems., Hacettepe University Scientific Research Projects Coordination UnitHacettepe University [THD-2018--17493], This study was funded by Hacettepe University Scientific Research Projects Coordination Unit, Project number: THD-2018--17493.

Objective To demonstrate the impact of preterm birth on the cytological, cytomorphometrical, and nuclear parameters of neonatal buccal smears. Methods This study consisted of Early Preterm Neonates (EPN; = 34th gestational week [gw]; n = 36), Late Preterm Neonates (LPN; 34th to 37th gw; n = 46), and Term Neonates (control; >= 37th gw; n = 56). Cytological evaluation and buccal cytome assay were performed using Papanicolaou and Feulgen methods, respectively. Results Cytological evaluation demonstrated that smear background was cleaner (P .05) and there were less macrophages in the control group (P .001). Cyto-morphometric analysis showed that the measurements of nuclear diameter, nuclear area, and nucleus-to-cytoplasm ratio were higher in the preterm (EPN and LPN) versus the control groups (P = .016, P .001, and P .001, respectively). We also demonstrated that staining intensity of the nucleus and cytoplasm were less intense in the EPN and LPN groups (P .001). There was no statistically significant difference between the EPN and LPN groups for any parameters (P > .05). Buccal cytome assay showed that nuclear buds were more prevalent in term newborns compared to preterm neonates (P .001). Conclusions Morphological and cytological properties of neonatal buccal cells are influenced by preterm birth status, and buccal smears may be used as a tool to detect biological markers of neonatal health problems., Hacettepe University Scientific Research Projects Coordination UnitHacettepe University [THD-2018--17493], This study was funded by Hacettepe University Scientific Research Projects Coordination Unit, Project number: THD-2018--17493.

Objective: to investigate the early neonatal outcomes of very-low-birth-weight (VLBW) infants discharged home from neonatal intensive care units (NICUs) in Turkey. Material and methods: a prospective cohort study was performed between April 1, 2016 and April 30, 2017. The study included VLBW infants admitted to level III NICUs. Perinatal and neonatal data of all infants born with a birth weight of.1500 g were collected for infants who survived. Results: data from 69 NICUs were obtained. The mean birth weight and gestational age were 1137 +/- 245 g and 29 +/- 2.4 weeks, respectively. During the study period, 78% of VLBW infants survived to discharge and 48% of survived infants had no major neonatal morbidity. VLBW infants who survived were evaluated in terms of major morbidities: bronchopulmonary dysplasia was detected in 23.7% of infants, necrotizing enterocolitis in 9.1%, blood culture proven late-onset sepsis (LOS) in 21.1%, blood culture negative LOS in 21.3%, severe intraventricular hemorrhage in 5.4% and severe retinopathy of prematurity in 11.1%. Hemodynamically significant patent ductus arteriosus was diagnosed in 24.8% of infants. Antenatal steroids were administered to 42.9% of mothers. Conclusion: the present investigation is the first multicenter study to include epidemiological information on VLBW infants in Turkey. Morbidity rate in VLBW infants is a serious concern and higher than those in developed countries. Implementation of oxygen therapy with appropriate monitoring, better antenatal and neonatal care and control of sepsis may reduce the prevalence of neonatal morbidities. Therefore, monitoring standards of neonatal care and implementing quality improvement projects across the country are essential for improving neonatal outcomes in Turkish NICUs., Turkish Neonatal Society