ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
ObjectiveTo systematically evaluate the efficacy and safety of anatomical landmark method (ALM) versus ultrasound (US)-guided internal jugular vein (IJV) catheterization in pediatric patients.
MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 10, 2016), CNKI, CBM, WanFang Data and CNKI were searched from inception to October 2016 to collect randomized controlled trials (RCTs) of landmark-guided versus ultrasound-guided IJV catheterization in pediatric patients who underwent elective surgery. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then RevMan 5.3 software was used to perform meta-analysis.
ResultsA total of 13 RCTs involving 1 026 pediatric patients were included. The results of meta-analysis showed that, the overall success rate (RR=1.21, 95%CI 1.09 to 1.34, P=0.000 5) and arterial puncture rate (RR=0.19, 95%CI 0.07 to 0.50, P=0.000 7) of US-guided IJV catheterization were both significantly superior to the ALM group. Whereas there was no significant difference between two groups as for the incidence of hematoma formation (RR=0.35, 95%CI 0.09 to 1.31, P=0.12).
ConclusionCurrent evidence shows that, for IJV catheterization of pediatric patients, both the effectiveness and safety of ultrasound-guided technique are better than the landmark-guided. Since the quantity and quality of included studies are limited, the conclusion of this study needs more high quality studies to verify.
Objective To evaluate the diagnosis value of purified protein derivative (PPD) antibody tests in childhood tuberculosis. Methods We reviewed 126 cases of hospitalization children tested body fluid PPD antibody by Enzyme-Linked Immunosorbent Assay (ELISA). Twenty-two them were diagnosed with tuberculosis. We determined the sensitivity, specificity, diagnostic likelihood ratio, positive prognostic value, negative prognostic value, post-test probability, respectively. Results The following accuracy statistics for the PPD body liquid antibody tests in this study: sensitivity, 45.45%; specificity, 91.35%; diagnostic likelihood ratio positive, 5.25; diagnostic likelihood ratio negative, 0.597; positive predictive value, 52.63%; negative predictive value, 88.79% and post-test probability, 48.09% in 15% of prevalence. Conclusion This study shows that body fluid PPD tests have limited value for diagnosis of tuberculosis in pediatric tuberculosis. Clinic physicians should be wary of the positive results of body fluid PPD antibody tests. The value of diagnosis is related to prevalence of tuberculosis in the specific hospital.
ObjectiveTo evaluate the robustness of pediatrics clinical evidence-based evidence using fragility index and to explore the factors influencing fragility index. MethodsWe searched the PubMed, Embase, and Scopus databases to collect relevant literature on systematic reviews and meta-analyses in the field of pediatrics, and calculated the fragility index. The rank sum test was used to compare differences between groups with different outcome types, different levels of statistical significance, and different sample sizes. Spearman correlation analysis was used to explore the association between the fragility index and sample size, as well as the year of publication. ResultsA total of 152 systematic reviews, including 573 meta-analyses, were included, with a median fragility index of 6 (3, 10). Most meta-analyses chose the risk ratio (RR) as the effect measure (387/573, 67.5%), the Mantel-Haenszel method (412/573, 71.9%) as the synthesis method, and the fixed-effect model (300/573, 57.4%) as the assumed model. The Mann-Whitney test showed no statistically significant difference in the fragility index between meta-analyses with safety outcomes and those with efficacy outcomes (P=0.397), and no statistically significant difference between meta-analyses with significant results and those with non-significant results (P=0.520). The Kruskal-Wallis test found a statistically significant difference in sample size among groups with different fragility indices (P<0.001). Spearman correlation analysis found a positive correlation between the fragility index and sample size (ρ=0.39, P<0.001), but no statistically significant correlation with the year of publication (P=0.235). ConclusionThe fragility index of systematic review and meta-analysis published in pediatrics journals is generally low, and the robustness of the results is not high, so it is necessary to be cautious when making evidence-based decisions. Furthermore, the larger the sample size included in the meta-analysis, the higher the fragility index, and incorporating more trials and populations can facilitate the increase in the robustness of the meta-analysis results.
Epilepsy, as a common neurological disorder in childhood, requires early diagnosis and intervention that are crucial for improving disease prognosis. Although traditional techniques such as electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) have made progress in pediatric epilepsy diagnosis and treatment, significant limitations remain in imaging-negative cases and in identifying deep lesions. Magnetoencephalography (MEG), a non-invasive neurophysiological technique with both high temporal and spatial resolution, has recently demonstrated unique advantages in localizing epileptogenic zones, analyzing functional connectivity, and identifying brain functional areas in children with epilepsy. In particular, the next-generation MEG systems based on optically pumped magnetometers (OPMs) have significantly broadened its applicability in pediatric populations. Nonetheless, practical use of OPM-MEG remains hindered by challenges such as non-standardized signal processing workflows, lack of agreement on dependable electrophysiological biomarkers, and the relatively high cost of devices. In the future, with continuous advances in multimodal integration, wearable device incorporation, and AI-assisted analysis, MEG is expected to achieve broader application in pediatric epilepsy diagnosis and treatment.
Objective To investigate the off-label prescriptions in pediatrics in West China Second University Hospital and to analyze the reasons and performance, so as to provide the baseline data for improving the rationality drug use in pediatrics in China. Methods The prescriptions of pediatrics outpatient department were randomly selected from May 2008 to April 2009; and the off-label use was analyzed according to the package inserts in the following aspects, the types of off-label use, the rate of off-label use in different age groups and categories of medicine. Results Of the total 2 400 prescriptions, 1 398 (58.25%) involving off-label use. All sample prescriptions contained 6028 records, 1 923 (31.90%) involving off-label use. The problems such as dosage (45.98%), frequency (21.17%) and age (18.19%) were the top-three types of off-label use. The rate in different age groups ranked as the top-three were school-age (61.56%), followed by preschool (60.77%) and infants (57.56). The top-five categories of medicines in off-label use were anti-allergy drugs (49.45%), digestive system drugs (49.32%), externally applied drugs (41.49%), Chinese patent drugs (34.60%) and nervous system drugs (33.78%). Conclusion The off-label drug use is widespread in pediatrics outpatient department. It is an effective approach to reduce off-label use and improve drug safety through strictly abiding by the instruction of usage and dosage as well as selecting a suitable dosage form.
Objective To systematically review the risk factors of tic disorder (TD) in children. Methods Databases including PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, CBM, VIP, and WanFang Data were electronically searched to collect observational studies on children with TD from inception to June 29th 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 32 studies involving 556 560 children were included. The results of meta-analysis showed that the risk factors for TD were as follows: male (OR=2.23, 95%CI 1.08 to 4.61, P=0.03), premature delivery (OR=1.66, 95%CI 1.04 to 2.64, P=0.03), low birth weight (OR=1.27, 95%CI 1.07 to 1.50, P=0.005), history of neonatal jaundice (OR=7.46, 95%CI 1.15 to 48.42, P=0.04), other adverse factors in the perinatal period (OR=2.74, 95%CI 1.89 to 3.98, P<0.000 01), poor eating habits (OR=2.11, 95%CI 1.52 to 2.93, P<0.000 01), long-term viewing of electronic products (OR=2.22, 95%CI 1.31 to 3.75, P=0.003), history of febrile convulsions (OR=2.43, 95%CI 1.21 to 4.86, P=0.01), recurrent respiratory infection (OR=2.63, 95%CI 1.49 to 4.64, P=0.000 8), chronic tonsillitis (OR=2.01, 95%CI 1.31 to 3.09, P=0.001), rhinopathy (OR=1.77, 95%CI 1.35 to 2.31, P<0.000 1), attention deficit hyperactivity disorder (ADHD) (OR=5.32, 95%CI 3.77 to 7.51, P<0.000 01), decreased blood iron content (OR=3.68, 95%CI 1.56 to 8.67, P=0.003), family history of TD (OR=6.33, 95%CI 3.20 to 12.53, P<0.000 01), family history of mental illness (OR=2.39, 95%CI 2.03 to 2.83, P<0.000 01), maternal mental disorder during pregnancy (OR=2.49, 95%CI 1.99 to 3.11, P<0.000 01), alcohol drinking during pregnancy (OR=1.40, 95%CI 1.09 to1.79, P=0.007), smoking or passive smoking during pregnancy (OR=1.84, 95%CI 1.68 to 2.01, P<0.000 01), and corporal punishment (OR=3.57, 95%CI 1.52 to 8.34, P=0.003). Parity (second birth and above) (OR=0.41, 95%CI 0.25 to 0.68, P=0.000 6) was a protective factor for tic disorder. Conclusions Current evidence shows that the incidence of TD is related to gender, family history of mental illness, maternal life habits during pregnancy, perinatal history, chronic respiratory diseases, abnormal trace elements, and strict education methods, etc. Moreover, parity is a protective factor for the occurrence of TD. Due to the limited quantity and quality of included studies, more high-quality studies are required to verify the above conclusions.
Objective
To explore the application of the Handbook for the Training Nurses in the standardized training for nurses in pediatric surgery.
Methods
Twenty-four training nurses trained under the instruction of the Handbook for the Training Nurses in Department of Pediatric Surgery from July 2014 to December 2015 were included as the observation group. Their training effects were compared historically with those of twenty-four training nurses who were trained without the help of the handbook from January 2013 to June 2014 (the control group).
Results
After the completion of the half-year training, theoretical score of training nurses in the observation group was better than that in the control group, and the difference was significant (87.16±4.18 vs. 83.71±5.46; t=2.492, P=0.016). Meanwhile, the specialist practical skill examination of training nurses in the observation group, such as femoral vein blood collection, replacement of drainage bag and indwelling needle infusion in children, and emergency practical skill examination such as cardiopulmonary resuscitation and the use of simple respirator were higher than those in the control group; and the working performance scores of training nurses in the observation group, such as the ability to adapt to the environment, patient satisfaction, nursing document writing, work efficiency and morning questions were better than those in the control group; the differences were significant (P< 0.05).
Conclusion
The Handbook for the Training Nurses can help the training nurses to adjust their working environment, master the practical skills and nursing knowledge in pediatric surgery.
ObjectiveTo explore the appropriate intervention measures to reduce the influence of drug repercussion by pediatric hospital inpatients on nursing work.
MethodBetween March 1st and 28th, 2014, statistical analysis on the characteristics of pediatric drug-return by drug repercussion questionnaires was carried out.
ResultsEach drug repercussion took much time of the nurses (median of 5.00 minutes per time). The frequency of drug repercussion in the internal medicine department was more than that in the surgical department; the most drug repercussions were found in the respiratory medicine department, reaching 26.84%. The main category of drug repercussion was aerosolized medication (39.32%). The drug repercussion mainly resulted from lack of patients' education and doctor-related administration, which had a proportion of 31.44% and 27.19%, respectively.
ConclusionsThe wards which have more drug repercussions should be under the supervision according to the analysis of drug repercussion. Meanwhile, improving patients' education and training of medical staff can reduce the pediatric hospital inpatients' drug repercussion and also may reduce the bad effects on nursing work.
Lumbar puncture for children is a difficult technique and is an important aspect of clinical teaching for residents and interns in the neurological department of pediatrics. In this article, we summarized techniques and experiences of clinical teaching in pediatric lumbar puncture, and discussed difficulty, variability and remedial strategy for lumbar puncture in children. Narrow intervertebral space, poor compliance and resistance of children are the main difficulty for pediatric lumbar puncture. The causes of failure for medical students include different sensations of breakthrough when using different needles, choice of un-preferable intervertebral space, excessive vertical angle for needling performance, deviation from the longitudinal midline of the body, incorrect anesthesia, and exceeding resistance of children patients. Corresponding remedial strategy for failure of puncture includes informing students of the technique and variability of puncture, training experienced staff for second- and third-line substitutes, and reinforcing nursing after surgery. This summary of techniques for pediatric lumbar puncture and experiences of clinical teaching will benefit pediatricians and their clinical training.
