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2,904 reports · page 158 of 291

Peer-reviewed articleOpenAlex31 Mar 2026

Safety and Efficacy of Intravenous Brivaracetam versus Levetiracetam in the Management of Status Epilepticus in Children

Status epilepticus (SE) is one of the most common pediatric neurological emergencies and a major cause of all pediatric epilepsy-related hospital admissions. Objectives: To compare the safety and efficacy of intravenous (IV) brivaracetam versus levetiracetam in the management of SE in children. Methods: This randomized controlled trial was performed at the Department of Pediatric Neurology, Institute of Child Health, Multan, Pakistan, from January to September 2025. A total of 152 children (76 in each group), aged 1 month to 16 years with SE, were randomly assigned to receive IV brivaracetam (2 mg/kg) or levetiracetam (40 mg/kg). Seizure cessation within 30 minutes of infusion, time to cessation, recurrence, hospitalization duration, and adverse events were documented. Data were analyzed using SPSS v26.0, with p<0.05 considered significant. Results: In a total of 152 children, the median age was 6.2 years (IQR 3.4–10.7), and 84 (55.3%) children were males. Seizure cessation within 30 minutes was noted in 65 (85.5%) children receiving brivaracetam and 55 (72.4%) receiving levetiracetam (p=0.047). The median time to cessation was 4.5 (IQR 3.0–7.0) minutes in bivarectam, vs. 6.0 (IQR 4.0–9.5) minutes with levetiracetam (p=0.009). The median hospital stay was 4.0 (IQR 3.0–6.0) days vs 5.5 (IQR 4.5–7.0) days (p=0.034) in brivarecetam and levetiracetam groups, respectively. Adverse events occurred in 10 (13.2%) children in the Bivaracetam group vs. 14 (18.4%) with levetiracetam (p=0.374), while no mortality was documented. Conclusions: IV brivaracetam achieves faster and more effective seizure cessation compared with levetiracetam in children with SE, with lower rates of adverse effects.

Ikram Ur Rahman, Muhammad Zubair Ahmad, Ali Umair Tariq

Peer-reviewed articleOpenAlex1 May 2026

Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial

INTRODUCTION: (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection. METHODS AND ANALYSIS: This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3-17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7-14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2-5) (online supplemental tables 1 and 2). Randomisation will be stratified by age (3-7 years vs 8-17 years). A standardised 'rescue therapy' protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48-72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged <8 years. Efficacy will be analysed using the intention-to-treat principle. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT07306234.

Youn Young Choi, Changmin Kang, Young June Choe et al.

KRRead at source

Peer-reviewed articleOpenAlex18 Mar 2020

Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis

Background: Midazolam is recommended by the guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive evidence for sedative-hypnosis and anti-anxiety by midazolam oral solution in children. Methods: Relevant studies were identified through searches of PubMed, Embase (Ovid), Cochrane Library, CINAHL, International Pharmaceuticals, four Chinese electronic databases, and relevant lists. Two reviewers independently selected trials, assessed trial quality, and extracted the data. Results: 89 RCTs comparing midazolam oral solution with placebo or blank (n =33), dexmedetomidine (n = 15), ketamine (n = 11), different midazolam doses (n = 10), midazolam injection (n = 8), chloral hydrate (n = 7), diazepam (n = 5), N2O (n = 5), triclofos (n = 4), butorphanol (n = 2), fentanyl (n = 2), hydroxyzine (n = 1), and thiopental (n = 1) were identified. Meta-analysis showed no significant difference in the success rate and duration of sedation and hypnosis between midazolam oral and injectable solution (P＞0.05). The success rate of sedation and hypnosis of midazolam was higher than that of ketamine [RR=1.32, 95% CI (1.07, 1.62), I2=0%, P<0.01]. No significant difference was found in the success rate of sedation and hypnosis, mask acceptance and parental separation between midazolam oral solution and dexmedetomidine (P＞0.05), and the result of one cohort study was consistent. The anxiety score of midazolam oral solution was higher than that of dexmedetomidine [MD=12.76, 95%CI (11.25, 14.27), P＜0.01]. The results of RCTs and prospective cohort study showed the incidence of ADR was 19.57% (189/966). Incidence of adverse reactions between (0.25, 0.5] mg/kg and (0.5, 1.0] mg/kg dose groups were similar [Pf (95% CI) =0.10(0.04, 0.24) and Pf (95% CI) =0.09(0.02, 0.39) respectively], higher than that of (0, 0.25] mg/kg dose group [Pf (95% CI) =0.01(0.00, 0.19)]. Conclusions: Available evidence suggests that midazolam oral solution is as good as midazolam injection and dexmedetomidine, and is better than ketamine. Based on efficacy and safety results, the dose of oral midazolam solution is recommended 0.5-1 mg/kg for children.

Xiao Cheng, Zhe Chen, Lingli Zhang et al.

CNRead at source

Peer-reviewed articleOpenAlex18 Dec 2024

The efficacy and safety of stepwise oral food challenge in children with hen’s egg allergy

BACKGROUND: Oral food challenge (OFC) is the gold standard for diagnosing food allergies (FAs) but carries the risk of anaphylactic reaction. Stepwise OFC, starting with a low dose of allergen and progressing to medium and full doses, is effective in determining a tolerable dose. We retrospectively evaluated the results of a stepwise OFC for hen's egg (HE) to demonstrate its safety and efficacy. We discuss whether early low-dose administration of HE induces early immune tolerance in HE allergy. METHODS: We included 2,058 children (median, 2.6 years) who underwent HE-OFC between 2017 and 2021 at two institutes in Japan. The target challenge dose of OFC was classified as low (less than 1/8 of a cooked egg), medium (1/8 or more but less than 1/2), or full (1/2 or more). If the low-dose OFC was negative, subjects were allowed to consume the same dose of HE and underwent medium-dose OFC within 12 months. Even if positive, individuals were recommended to consume previously-tolerated amounts of HE and repeat OFC at the same dose within 12 months. We evaluated the correlation between their OFC results and response. RESULTS: A total of 526 (25.6%) children presented positive reactions. There were no cases of anaphylactic shock. Higher serum egg white (EW)- (P < 0.001) and ovomucoid (OVM)- specific IgE (P < 0.001) (sIgE) levels were associated with positive OFC. The low-dose OFC group had more positive reactions (P < 0.001), younger children (P < 0.001), higher EW-sIgE (P < 0.001) and OVM-sIgE (P < 0.001), and more histories of anaphylaxis (P = 0.014). OFC-positive children were younger than OFC-negative children, particularly in low-dose OFC (P = 0.010). OFC results between complete and partial elimination of HE groups across all EW- or OVM-sIgE classes were similar (P > 0.05). CONCLUSIONS: Stepwise OFC is safe and effective in diagnosing HE allergy and facilitates the earlier introduction of HE in children. This study suggests the limited potential of early consumption of lower doses of HE to induce earlier immune tolerance, such that other strategies to induce earlier tolerance in infants with HE allergy should be considered.

Mika Ogata, Jun Kido, Takanobu Yoshida et al.

JPRead at source

Peer-reviewed articleOpenAlex1 Jan 2022

Systematic Review of the Efficacy and Safety of Traditional Chinese Medicine Granules Associated with Hormone When Treating Primary Nephrotic Syndrome in Children

Objective. To systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) granules associated with hormones when treating primary nephrotic syndrome (PNS) in children. Methods. Search online databases such as PubMed, EMBASE, ScienceDirect, Cochrane Library, China Knowledge Network Database (CNKI), China VIP Database, Wanfang Database, and China Biomedical Literature Database (CBM) to search for information on the use of hormone‐related Chinese medicine granules in the treatment of children with PNS controlled trials. Retrieval time was limited to the period from the date the database was established to the present. Separately, two researchers gathered the data. Statistical software RevMan5.4 was adopted to estimate bias risk in accordance with the Cochrane Handbook 5.3 standard. Results. Finally, 7 articles were selected with a total sample size of 487 cases. The infection rate, recurrence rate, and adverse reaction rate after treatment were analyzed by meta‐analysis. The infection rate and recurrence rate in the study group were notably lower, and the difference was statistically significant (P < 0.05). However, the incidence of adverse reactions exhibited not notably different (P > 0.05). The levels of albumin and blood cholesterol after treatment indicated no statistical difference between the levels (P > 0.05). Meta‐analysis was performed on the time to negative urine protein and the time to edema subsidence after treatment. The urine protein negative time and edema subsidence time of the study group were shorter after treatment, but the difference exhibited not notable (P > 0.05). Meta‐analysis was performed on the dosage of glucocorticoids after treatment. The dosage of glucocorticoid in the study group was notably lower, and the difference was statistically significant (P < 0.05). The levels of T lymphocytes after treatment were analyzed by meta. T lymphoid level in the study group was notably better after treatment, and the difference was statistically significant (P < 0.05). Further subgroup analysis indicated that the levels of CD3+ and CD4+ in the study group were higher after treatment (P < 0.05), and there exhibited no statistical difference in the levels of CD8+, CD4/CD8+, and CD19 (P > 0.05). Immunoglobulin levels in the study group after treatment were notably better, and the difference was statistically significant (P < 0.05). Further subgroup analysis indicated that the levels of IgA, IgM, and IgG in the study group were notably higher after treatment, and the difference was statistically significant (P < 0.05). Conclusion. Huai Qi Huang can reduce the recurrence rate of PNS children and the incidence of infection and the dosage of prednisone. A long‐term application can improve the cellular and humoral immune function of children with PNS. It has high treatment safety and has no notable effect on plasma cholesterol levels, so it is suitable for clinical application.

Li Zhang, Lei Chen

CNRead at source

Peer-reviewed articleOpenAlex1 Jun 2018

Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children

BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed. The Phase I study results are presented here. METHODS: This was a randomized, observer-blinded Phase I study to assess the safety and immunogenicity of Vi-DT compared to Vi polysaccharide vaccine, conducted in Manila, Philippines. Participants enrolled in an age de-escalation manner (18-45, 6-17 and 2-5 years) were randomized between Test (Vi-DT, 25 µg) administered at 0 and 4 weeks and Comparator (Vi polysaccharide, Typhim Vi® and Vaxigrip®, Sanofi Pasteur) vaccines. RESULTS: A total of 144 participants were enrolled (48 by age strata, 24 in Test and Comparator groups each). No serious adverse event was reported in either group. Solicited and unsolicited adverse events were mild or moderate in both groups with the exception of a 4-year old girl in Test group with grade 3 fever which resolved without sequelae. All participants in Test group seroconverted after first and second doses of Vi-DT while the proportions in the Comparator group were 97.1% and 97.2%, after first dose of Typhim Vi® and second dose of Vaxigrip®, respectively. Vi-DT showed 4-fold higher Geometric Mean Titers (GMT) compared to Typhim Vi® (adjusted for age strata, p < 0.001). No further increase of GMT was detected after the second dose of Vi-DT. Anti-DT IgG seroresponse rates were 81.2% and 84.5% post first and second Vi-DT doses, respectively. CONCLUSIONS: Vi-DT vaccine was safe, well-tolerated and immunogenic in participants aged 2-45 years. ClinicalTrials.gov registration number: NCT02645032.

María Rosario Capeding, Samuel Teshome, Tarun Saluja et al.

SurvivalPHRead at source

Every report we find, newest first.

How to use the reports

Safety and Efficacy of Intravenous Brivaracetam versus Levetiracetam in the Management of Status Epilepticus in Children

Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial

Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis

Introduction to Technology and Its Impact on the Indonesian Migrant Children in Malaysia

Knowledge and attitude of children safety at home among population in Saudi Arabia

The efficacy and safety of stepwise oral food challenge in children with hen’s egg allergy

Systematic Review of the Efficacy and Safety of Traditional Chinese Medicine Granules Associated with Hormone When Treating Primary Nephrotic Syndrome in Children

Effectiveness and Safety of SARS-CoV-2 Vaccines among Children and Adolescents: A Systematic Review and Meta-Analysis

Long-term safety and efficacy of fecal microbiota transplantation in 74 children: A single-center retrospective study

Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children

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