Pediatrics International最新文献

Background: Pediatric pharmacokinetics (PK) differ from adults due to their unique developmental stages and physiological immaturity. However, the lack of pediatric-approved drugs often necessitates the off-label use of adult-approved medications, thereby burdening the healthcare providers with dosing decisions and leaving pediatric efficacy and safety uncertain. We defined pediatric off-label use as the prescription to pediatric patients of medications for which only dosages for adults are specified in the package insert and quantified its prevalence in Japan.

Methods: Data from the National Database (NDB) sampling dataset (July and October 2022 and January and April 2023) on oral/injectable medications prescribed to children aged 0-14 years were analyzed to assess off-label pediatric use. Cross-tabulations were conducted to examine pediatric indication categories, as specified in package inserts, across different pediatric age groups and Anatomical Therapeutic Chemical (ATC) classifications. Due to the higher prevalence of off-label use among inpatients, detailed analyses quantified the proportion of pediatric off-label users by ATC level 2 (≥150 users) and identified specific active substances used off-label in neonates/infants (≥50 users).

Results: Overall, pediatric off-label use was 24% in inpatients and 14% in outpatients. Notable variability was observed across the ATC classifications. Specifically, the off-label use was 1.9% for antibacterials (J01), 32.5% for antineoplastics (L01), and 65.5% for diuretics (C03).

Conclusions: This NDB-based study offers foundational nationwide data on pediatric off-label use, revealing delays in pediatric medication development and inconsistencies in package inserts that vary across age groups and therapeutic areas, insights that can help improve safety and optimize pediatric healthcare delivery.

Background: The combination of thiopurines and partial enteral nutrition (TP/PEN) is a common maintenance therapy for mild-to-moderate Crohn's disease (CD) in pediatric patients. However, no studies have investigated the efficacy of TP/PEN. This study aimed to evaluate the non-relapse and complete mucosal healing rates in pediatric CD patients following treatment with or without TP, in addition to PEN.

Methods: This retrospective observational study included 39 pediatric patients diagnosed with mild-to-moderate CD. Based on the proposed treatment, the patients were divided into the TP/PEN and PEN-only groups. The primary outcome was the relapse-free rate between the two groups. Relapse was defined as a pediatric Crohn's disease activity index (PCDAI) >12.5, Simple Endoscopic Score-CD (SES-CD) score >7, Lewis score > 135, and/or abnormal C-reactive protein levels (CRP > 0.15 mg/dL). The secondary outcome was complete mucosal healing (SES-CD score 0) at 12-24 months.

Results: Although the difference in non-relapse rate between the two groups was not statistically significant, complete mucosal healing rates were significantly higher in the TP/PEN group than in the PEN-only group. Complete mucosal healing at 12-24 months was achieved in 7/21 (33.3%) and 1/18 (5.5%) patients in the TP/PEN and PEN-only groups, respectively (p < 0.05).

Conclusion: Nowadays, more treatment options are available, and TP/PEN remains a viable option for the treatment of mild-to-moderate CD in pediatric patients.

Background: To assess the clinical validity and reliability of the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) for acute pain in infants with illnesses treated in the neonatal intensive care unit (NICU).

Methods: Data of 32 infants were collected. NICU nurses measured pain and distress scores using the Japanese version of the N-PASS (henceforth, N-PASS-J) at baseline and during skin puncture. To determine internal consistency, discriminant validity, and convergent validity, we calculated Cronbach's alpha, conducted a one-way repeated measures ANOVA, and examined correlation coefficients with established pain measurement tools.

Results: Data were collected for 122 scenes: 61 at baseline and 61 at the time of the skin puncture. The median (IQR) gestational age of participants was 32 (29-37) weeks, and corrected gestational age at measurement was 33 (30-37) weeks. Cronbach's alpha for the five N-PASS-J items was 0.93. Pain and distress scores were significantly higher at the time of blood collection than at rest (mean ± SD) (baseline: 0.3 ± 0.6; skin puncture: 5.2 ± 2.4, F (1, 120) = 232.5, p < 0.0001). The correlation coefficient between the distress scores and the Face Scale for Pain Assessment Preterm Infant score was 0.91.

Conclusions: The N-PASS-J is a dependable and valid instrument for assessing acute pain in infants with illness treated in the NICU.

Background: Late preterm infants, born between 34 and 36 weeks of gestation, generally have a better clinical prognosis than those born before 33 weeks. However, detailed differences within the late preterm group have been underexplored. Therefore, this study compared the clinical outcomes of infants born at 34 and 35 weeks of gestation.

Methods: Hospital records between April 2020 and March 2024 were retrospectively analyzed, excluding cases with complications. Statistical comparisons were performed using Fisher's χ² test, Mann-Whitney U test, and simple linear regression.

Results: Infants born at 34 weeks had lower appearance, pulse, grimace, activity, and respiration (Apgar) scores at 1 and 5 min, with a significant decrease in respiratory scores at 5 min (1-point score: 60.00% vs. 18.18%, p = 0.0041). They were also significantly more likely to require respiratory assistance at birth without specific respiratory intervention (p < 0.0001). Although birth weight showed no significant difference, 34-week-old infants had a longer duration of intravenous therapy, took longer to establish autonomous feeding, and had an extended hospital stay (median: 17 days vs. 10 days, p = 0.0017). Prolonged stays were not correlated with the duration of oxygen use or weight but were more strongly associated with feeding difficulties in 34-week-olds (r = 0.9187, p < 0.0001).

Conclusion: A 1-week gestational age difference in late preterm infants represents a significant clinical distinction. Infants at 34 weeks had prolonged hospital stays driven by feeding difficulties, not respiratory morbidity, challenging current uniform management approaches.

Background: Understanding infectious disease seasonality is crucial to inform immunization timing and risk communications. This study aimed to describe trends in respiratory syncytial virus (RSV) seasonality in Japan by determining thresholds across 47 prefectures using public health surveillance data.

Methods: Weekly RSV cases per sentinel (CPS) is the main indicator used in Japan. Data from approximately 3000 pediatric sentinel sites were extracted for 2012-2024. Seasonal, advisory, and alert thresholds were established via two globally utilized methods (moving epidemic methods [MEM] and fixed threshold method). Based on the established seasonal threshold, onset/duration was examined for each season during the study period.

Results: The fixed threshold method was finally chosen to establish the seasonal threshold, while medium and high-intensity thresholds under the MEM methods were chosen as advisory and alert thresholds. The threshold values were 0.23-0.80CPS for seasonal, 0.75-2.82CPS for advisory, and 1.11-4.20CPS for alert. The epidemic periods usually lasted less than 6 months, with distinct epidemic peaks in almost all prefectures over the 13-year observation. However, unlike other temperate countries/regions such as the United States and Europe, season onset shifted drastically from September-October in 2012/2013 to around March-April in 2024 with geographic variabilities. Calling season onset after 2 consecutive weeks above the threshold resulted in no false alarms in over half the prefectures.

Conclusions: In countries such as Japan and the tropics/subtropics where the RSV seasons are less predictable, a flexible prevention strategy, tailored for each region/prefecture, using thresholds as guides, would ensure optimal protection against RSV and maximize public health benefits regardless of seasonal variability.

Background: Bottom shuffling (BS) occurs in ordinary infants without developmental disorders; however, the incidence and the related factors have been unclear. This study aimed to investigate the occurrence of BS in ordinary developing infants and the potential effects of parental intervention on the BS occurrence.

Methods: A questionnaire survey on BS was conducted among 241 parents of 0-year-old and 1-year-old children in nursery schools, randomly selected from urban and rural areas in three prefectures in Japan.

Results: Of the 241 infants without developmental disorders, 52 infants (21.6%) exhibited BS from 6 to 18 months of age (average: 8.3 ± 2.0 months). The ages of starting creeping, crawling, and unsupported sitting were 6.9 ± 1.8, 8.6 ± 1.8, and 7.0 ± 1.4 months of age, respectively. While the age of acquisition for creeping, crawling, or sitting did not differ due to BS, a correlation was found between BS incidence and parents' understanding of sitting development. Of the 241 parents, 110 parents responded that the timing of their infant's learning of "how to sit" should come just after their start of rolling over. In the infants with the 110 parents, a significant high frequency of the BS occurrence (27.3%, 30 out of 110) was observed.

Conclusions: BS may lead to a decrease in opportunities for full-body prone activity resulting in reduced physical activity, which raises concerns about the infant's autonomy.

Background: Pulmonary exacerbations (PEs) are associated with a subsequent decline in lung function. We aim to evaluate lung function in cystic fibrosis (CF) patients with frequent PEs in their first 2 years of age using spirometry at age 6.

Methods: This retrospective cohort study included CF patients who were 6 years old from the CF registry of Turkey in 2019. According to the number of PEs, patients were classified: those who had two or fewer PEs in the first 2 years of age were defined as Group 1 and those who had more than two PEs were defined as Group 2. The patients' demographics and clinical characteristics were compared between Group 1 and Group 2.

Results: The study included 88 patients who had data on PE from their first 2 years and completed their sixth year by 2019. Fifty-nine patients were included in Group 1 and 29 in Group 2. The mean percent-predictive FEV1 (ppFEV1), percent-predictive FVC (ppFVC) values, and the mean age at first PE were lower in Group 2 than in Group 1 (p = 0.019, p = 0.017, p < 0.001). The patients with chronic Pseudomonas aeruginosa (PA) colonization had lower mean ppFEV1 and ppFVC values than those without (p = 0.001, p = 0.001). Patients with PA in respiratory-sample culture during their first PE had lower ppFEV1 and ppFVC values than those with SA (p = 0.046; 0.018).

Conclusions: This study showed that more frequent PEs in the first 2 years of age and chronic PA colonization were associated with poorer FEV1, FVC, and BMI values in CF patients.