Journal of Pediatric Pharmacology and Therapeutics最新文献

Objective: To evaluate the association between hydrocortisone (HC) and dexamethasone (DEX) exposure in the NICU on neurodevelopmental (ND) outcome in extremely preterm (EPT; GA <28 weeks) infants.

Methods: This is a single-center retrospective cohort chart review of EPT infants born between 2011 to 2016 compared in terms of ND outcome at 20 months corrected age (CA). Steroid exposures, sociodemographic factors and neonatal comorbidities were collected. Outcome measures included neurologic exam and -Bayley-3 testing. Multiple regression analyses adjusted for effects of risk factors on outcome.

Results: Of the 221/264 survivors, 138 had no steroid exposure, 47 received HC only and 36 received DEX ± HC. Steroid-exposed groups were of lower birth weight and gestational age and had higher rates of neonatal comorbidities. Total duration and cumulative dosage of HC was not significantly different between steroid-exposed groups. Infants exposed to DEX ± HC had significantly lower Bayley-3 indices as compared with the no-steroid and HC only group. In linear regression analyses, DEX ± HC was associated with a 10-point reduction in cognitive (p < 0.01), language (p < 0.05), and motor (p < 0.01) indices.

Conclusions: In EPT infants, prolonged, repeated steroid exposure with DEX ± HC was associated with adverse cognitive, language and motor outcomes at 20 months CA. Further research may expose the -cumulative effect of steroids in this vulnerable population.

Objective: The use of olanzapine for control of chemotherapy-induced vomiting (CIV) has increased; however, data on safety and efficacy in pediatric patients are limited. The primary objective of this study is to assess olanzapine for the prevention of refractory CIV in pediatric oncology patients.

Methods: This study is a retrospective, cross-control study of patients admitted to a pediatric hematology oncology service. Complete control of CIV was defined as no documented emesis and no administration of rescue antiemetics. For inclusion, patients had to have 1 encounter without and 1 encounter with olanzapine. Exclusion criteria included olanzapine use outside of CINV indication or olanzapine administration occurring after the start of chemotherapy.

Results: A total of 26 patients were included, with a median age of 14 years (IQR, 11.74-15.26) and median baseline weight of 56.2 kg (53.35-68.83). The median olanzapine dose administered was 0.089 mg/kg/dose. Olanzapine administration resulted in a higher number of patients achieving complete control of CIV (30.7% vs 11.5%; p = 0.001), reduction in doses of rescue antiemetic agents administered (1 vs 3 doses; p = 0.0117), but increase in documented somnolence by nurse assessment in patients receiving olanzapine (15.4% vs 7.7%; p < 0.001).

Conclusion: The addition of olanzapine appears effective at achieving complete control of CIV when used for the prevention of refractory CIV.

The Pediatric Pharmacy Association (PPA) strongly urges health care institutions to establish and support the pharmacist's role in pediatric emergency department (ED) settings. Adult patient-centric guidelines have firmly established the general role of the pharmacist and pharmacy services in emergency medicine; however, pediatric pharmacy presence is often considered in case-based scenarios, such as pediatric cardiopulmonary resuscitation events. PPA recommends supporting the pharmacist's role in all pediatric ED settings and scenarios including, but not limited to, participation in direct patient care activities, education, safety, improvement initiatives, and transitions of care. Further, PPA advocates for the provision of appropriate training, credentialing, and ongoing mentorship and competency in these areas.

Objective: To review pediatric data on vancomycin exposure threshold against methicillin-resistant Staphylococcus aureus (MRSA) and coagulase-negative staphylococci (MR-CoNS).

Methods: A systematic review was conducted through July 2023. Publications in English that explored vancomycin effectiveness threshold against MRSA, CoNS, or S aureus in pediatrics were eligible. Effectiveness examined included clinical improvement, microbiologic sterilization, recurrence, and mortality, as defined by each individual study.

Results: Twelve studies were eligible. One on MRSA bacteremia (MRSA-B) identified an area under the curve to minimum inhibitory concentration ratio (AUC:MIC) of 300 mg × hr/L associated with rapid bacteremia clearance. Two on CoNS bacteremia (percentage of MR-CoNS unreported) demonstrated an AUC of 300 mg x hr/L regardless of MIC and an AUC:MIC of 280 mg × hr/L for bacteriologic cure, respectively; and one on S aureus bacteremia (25.5% MRSA) found an AUC:MIC of 400 mg × hr/L for clinical improvement.

Conclusions: There is overall limited pediatric data, and the observed AUC:MIC thresholds should be interpreted as hypothesis generating only. Further, the effectiveness outcome could be refined in future research by using time to bacteremia clearance only, as odds of complications increase with each additional day of MRSA-B, whereas the definition of recurrence is not standardized, and mortality is low. Additionally, extrapolating AUC:MIC for MRSA to CoNS is beyond the stated usage of current guidelines. To achieve an AUC:MIC ratio against CoNS with a MIC of >1 mg/L would require higher AUC with potential nephrotoxicity. More data on AUC (regardless of MIC) for MR-CoNS bacteremia are needed.

Asparaginase is a standard treatment for acute lymphoblastic leukemia (ALL) of childhood. As a bacteria-derived enzyme, asparaginase is highly immunogenic, and hypersensitivity reactions (HSRs) routinely lead to drug discontinuation. HSRs remain common even with the introduction of pegaspargase, a PEGylated version of Escherichia coli-derived asparaginase. Asparaginase Erwinia chrysanthemi (recombinant)-rywn (recombinant Erwinia) is an alternative for those with HSRs to pegaspargase. Here, we describe an 11-year-old boy with relapsed ALL who developed HSRs to both pegaspargase and recombinant Erwinia. This is the report of a novel desensitization protocol for calaspargase pegol-mknl (calaspargase) with no adverse events and adequate serum asparaginase activity.

Objectives: Erythromycin has been utilized for gastroparesis and feeding intolerance in adults and neonates, but limited studies exist for infants and children. The purpose of this study was to evaluate the safety and efficacy of erythromycin for gastroparesis in pediatric patients. The primary objective was to identify the number of patients with gastroparesis improvement, defined as no additional use of promotility agents, no erythromycin dose increases or need for other interventions (transpyloric or gastrostomy-jejunostomy tube). Secondary objectives included comparisons of clinical characteristics and outcomes between those with and without gastroparesis improvement and identification of patients with QTc prolongation following erythromycin initiation (QTc interval >450 ms or ≥25% increase from baseline).

Methods: This retrospective study included patients >28 days to <18 years of age receiving erythromycin for gastroparesis for ≥48 hours between August 1, 2019 to August 31, 2022. Comparisons were performed using Wilcoxon 2-sample test, χ², or Fisher exact tests.

Results: Gastroparesis improvement was noted in 40 (59.7%) of 67 included patients. Patients without improvement were significantly younger than those with improvement, median (IQR) 2 (1.0-3.0) vs 3.5 (1.5-6.5) years, respectively (p = 0.038). Patients with improvement had a significantly shorter treatment duration than those with no improvement, 4 (3-8) vs 9 (5-19) days (p = 0.01). Of the 37 patients who had an electrocardiogram obtained, 4 patients (10.8%) had QTc prolongation but did not develop dysrhythmias.

Conclusions: The majority had gastroparesis improvement with erythromycin therapy. Those without improvement were younger and had a longer erythromycin treatment course. QTc prolongation occurred in 4 patients; no dysrhythmias were noted.

Children often experience viral illnesses causing respiratory symptoms. Frequently, nonprescription medications are used in an attempt to decrease the severity and frequency of cough and cold symptoms. Cough and cold medications (CCMs) are not appropriate for all age groups and can have serious adverse effects, including death, especially when used incorrectly. Data surrounding the safety and efficacy of CCMs in patients younger than 6 years are lacking. Currently, the US Food and Drug Administration (FDA) does not recommend the use of cough and cold products that contain an antihistamine or decongestant in children younger than 2 years. Other treatments used by patients for cold symptoms include non-pharmacologic therapies or complementary alternative medications (CAMs), such as zinc or echinacea. Given this is a common ailment for pediatric patients, pharmacists should be knowledgeable about the risks and benefits of each of these therapies to make safe recommendations for patients and their families. This review discusses various cough and cold therapies and the recommendations for their use in pediatric patients.

Infantile hemangioma (IH) is the most prevalent benign vascular tumor among infants. While most hemangioma cases typically undergo spontaneous resolution, there is a risk of complications and concern over changes in appearance in certain circumstances. The treatment options include oral and topical drug therapy, laser therapy, and surgery. Because the lesions are (but not exclusively) formed on the skin's surface and exhibit features typical of tumors, there are opportunities for implementing nanoparticle technology for systemic and topical treatments. Nanotechnology in drug delivery generally aims to boost the efficacy of substance penetration or absorption, prevent systemic side effects by passive or active targeting, prolong effectiveness, and reduce the dose and duration of treatment. Several types of nanoparticles have been selected as research subjects in nanoparticle-based studies for treating IH. The type of nanoparticle is chosen based on evaluations of many factors, such as the active substance's physical and chemical compatibility, target site, and route of administration, and the formula is constructed by using an optimization process, resulting in a system with distinctive advantages.

Objective: The coronavirus pandemic led to many supply chain shortages including parenteral nutrition (PN) components, and for our institution, a critical shortage of calcium gluconate vials. Our institution switched to an alternative product, calcium gluconate in sodium chloride (Ca-gluconate-in-NaCl), and owing to lack of specific gravity data, it could not be placed as an additive in our compounder. Instead, it had to be used as a continuous infusion, co-infused with PN. The purpose of this study was to determine if the alternative product led to significant electrolyte abnormalities affecting calcium homeostasis in patients requiring PN.

Methods: This was a retrospective review of the electronic health record for all infants aged 0 days to 12 months from March 1, 2022, through May 31, 2022, who received PN and a continuous Ca-gluconate-in-NaCl infusion at our institution. Associations between dosing and adverse events were explored with ordinal and logistic regression.

Results: A total of 39 patients were included in our study. Ca-gluconate-in-NaCl was provided with PN for a median of 7 days. Hypocalcemia occurred in 16 of 39 (41%) study infants. Seven patients experienced mild hypocalcemia (8-8.5 mg/dL; p = 0.875), 7 experienced moderate hypocalcemia (7-7.9 mg/dL; p = 0.339), and 2 experienced severe hypocalcemia (<7 mg/dL; p = 0.214). One patient who experienced severe total serum hypocalcemia also experienced hypocalcemia as defined by ionized calcium concentrations (<1.1 mmol/L; p = 0.344).

Conclusions: Ca-gluconate-in-NaCl infused via Y-site with PN could be a viable alternative during shortage of calcium gluconate vials for at least 7 days in infants requiring PN.

Objective: The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the pediatric intensive care unit (PICU).

Methods: This was a prospective randomized, double-blind, placebo-controlled pilot trial in an academic PICU over 1 year. Patients ≤ 17 years who required antibiotic therapy ≥ 72 hours were randomly assigned to receive placebo or LGG. Exclusion criteria included antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and gastrointestinal (GI) disorders. LGG (30 × 10⁹ colony forming units) or a matching placebo capsule was administered twice daily for the duration of antibiotic therapy. Diarrhea was defined as 3 or more loose stools in 24 hours.

Results: A total of 36 patients were enrolled with 19 patients eligible for final analysis; 10 in the LGG group and 9 in the placebo group. Median age and weight of LGG vs placebo groups were 0.4 (0.17-1.42) vs 0.86 (1.21-10.92) years, p = 0.48, and 6 (3.4-9.9) vs 9.8 (3.71-39.6) kg, p = 0.31, respectively. Antibiotic associated diarrhea was experienced in 30% vs 55.5% of patients in the LGG groups vs placebo (p = 0.375), respectively. The median PICU length of stay for the patients with AAD was 6 days compared with 7.5 days in placebo group (p = 0.033). The RR ratio for AAD when using LGG was 0.59 (95% CI, 0.21-1.6). No adverse events were reported or attributed to LGG.

Conclusion: Results of this pilot study indicate that LGG is safe and could potentially reduce the incidence of AAD in the critically ill pediatric patients at this academic institution. Our findings suggest clinicians should consider the use of LGG in appropriate PICU patients.