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  1. Nor AM, Jagdeesh K, Mohd FAS, Kamraul AK, Yusmadi A, Noraslawati R, et al.
    Med J Malaysia, 2023 Nov;78(6):756-762.
    PMID: 38031217
    INTRODUCTION: The study aims to evaluate and report on the clinical characteristics, incidence, risk factors and associated complications of emergency and planned peripartum hysterectomy in a single training and research tertiary health care centre in Malaysia.

    MATERIALS AND METHODS: We conducted a 6-year retrospective cross-sectional study from the 1st January 2016 until 31st December 2021. Clinical, demographic characteristics, perioperative parameters, operative indications, blood loss, maternal/neonatal outcomes and complications were analysed. Patients were subdivided, analysed and studied in two subgroups- emergency hysterectomy (EH) and planned hysterectomy (PH).

    RESULTS: There were 65 cases of peripartum hysterectomy out of total 100,567 deliveries, with a prevalence rate of 0.06%. Overall, the majority of patients were multiparous (96.9%), having previous caesarean scar (73.8%) or diagnosed with placenta praevia (75.4%). More than half of the total patients (61.5%) have both previous caesarean scar and concomitant placenta praevia. EH was carried out in 39(60%) patients while 26(40%) patients underwent PH. The only indication for surgery in the PH group (100%) was abnormal placentation while the most common indication for surgery in the EH group (53.8%) was postpartum haemorrhage related to abnormal placentation. Patients who underwent EH were more likely to have massive blood loss (p=0.001), require ICU admissions (p=0.001), have DIVC cycles transfused (mean [SD] regime: 1.35 [0.95] vs 0.54 [0.99]; p=0.002), have lower postoperative haemoglobin level (mean [standard deviation, SD] haemoglobin: 9.23g/l [SD1.8] vs. 10.8 g/l [SD1.86]; p=0.001) and have higher difference between pre/post operative haemoglobin level (mean [SD] haemoglobin difference: 1.78g/l [SD6.34] vs 0.32g/l [SD1.7]; p=0.008) compared to patients with PH. Red blood cell transfusion, operating time, length of stay, weight of babies and Apgar score between two groups showed no significant differences. A significant reduction of blood loss between the first and the second half duration of the study (mean [SD] blood loss: 6978 ml [SD 4999.45] vs. 4100ml [SD2569.48]; p=0.004) was also observed. In the emergency group, 'non-placental cause' EH required significantly more red blood cell transfusion than 'placental cause' (p<0.05) while in the PH group, no significant difference was observed between the occlusive internal iliac artery 'balloon' and 'no balloon' subgroup in terms of operating time, total blood loss or blood transfusion. Overall complications showed more cases of post operative fever and relaparotomy in the EH group (18.4% vs. 7.6%) while urinary tract injuries including injuries to bladder and ureter occurred only in the PH group (9.4% vs. 0%).

    CONCLUSION: The majority of peripartum hysterectomy cases are due to placenta accreta spectrum disorders. Planned peripartum hysterectomies have a lower morbidity rate compared to emergency hysterectomies. Therefore, early identification of placenta accreta spectrum disorders and timely planning for elective procedures are crucial to minimise the need for emergency surgery.

    Matched MeSH terms: Infant, Newborn
  2. Tan SL, Ahmad Narihan MGB, Koa AJ
    BMC Pediatr, 2023 Oct 28;23(1):541.
    PMID: 37898736 DOI: 10.1186/s12887-023-04376-5
    BACKGROUND: Coffin-Lowry syndrome (CLS) is a rare X-linked condition with intellectual disability, growth retardation, characteristic facies and skeletal anomalies. To date, hypertriglyceridemia has not been reported in literature to be associated with CLS.

    CASE PRESENTATION: Herein, we report a case of very severe hypertriglyceridemia 32 mmol/L (2834 mg/dL) detected incidentally at three months old in an otherwise well boy born late preterm with intrauterine growth restriction, when he presented with lipaemic plasma. He was later diagnosed with CLS. No pathogenic mutations were found for hypertriglyceridemia, and no secondary causes could explain his very severe hypertriglyceridemia.

    CONCLUSIONS: The very severe hypertriglyceridemia in this case may appear to be a serious presentation of an unrecognised clinical feature of CLS, further expanding its phenotype.

    Matched MeSH terms: Infant; Infant, Newborn
  3. Foong WC, Foong SC, Ho JJ, Gautam D, Leong JJ, Tan PY, et al.
    BMC Pregnancy Childbirth, 2023 Oct 03;23(1):706.
    PMID: 37789260 DOI: 10.1186/s12884-023-06021-6
    BACKGROUND: The updated World Health Organization (WHO) guideline recommends immediate kangaroo mother care (KMC) for all infants, particularly those born preterm. However, its uptake and sustainability have been unsatisfactory. Therefore, we aimed to gain deeper insight into factors influencing the uptake of KMC practice in our setting, and thereby identify possible solutions for the development of relevant interventions to improve its adoption and make KMC a routine practice for all infants.

    METHODS: Using the Triandis model of social behaviour as our framework, we conducted key informant interviews with parents and healthcare providers. Trained interviewers conducted interviews with nine parents, recruited via purposive sampling. These parents were parents of preterm infants who had been introduced to KMC. Data was transcribed and analysed based on Triandis' Theory of Interpersonal Behaviour. This paper only reports the results of the parent interviews.

    RESULTS: Major findings were how positive feelings like warmth and contentment, the sense of parenthood with KMC, the benefits of KMC for their infant and parents being enablers for KMC uptake. Conversely, the lack of KMC awareness, the initial negative feelings such as fear, uncertainty and embarrassment, the prioritization of time for milk expression, overcrowding in the ward, lack of space and privacy, limited visiting hours, lack of support and poor communication resulting in misapprehension about KMC were major barriers.

    CONCLUSION: A deeper understanding of the factors influencing the uptake of KMC using the Triandis behavioural model provided a way forward to help improve its uptake and sustainability in our settings.

    TRIAL REGISTRATION: This study was registered with the National Medical Research Registry (NMRR-17-2984-39191).

    Matched MeSH terms: Infant; Infant, Newborn; Infant, Premature*
  4. Hong J, Crawford K, Odibo AO, Kumar S
    Am J Obstet Gynecol, 2023 Oct;229(4):451.e1-451.e15.
    PMID: 37150282 DOI: 10.1016/j.ajog.2023.04.044
    BACKGROUND: Determining the optimal time of birth at term is challenging given the ongoing risks of stillbirth with increasing gestation vs the risks of significant neonatal morbidity at early-term gestations. These risks are more pronounced in small infants.

    OBJECTIVE: This study aimed to evaluate the risks of stillbirth, neonatal mortality, and severe neonatal morbidity by comparing expectant management with delivery from 37+0 weeks of gestation.

    STUDY DESIGN: This was a retrospective cohort study evaluating women with singleton, nonanomalous pregnancies at 37+0 to 40+6 weeks' gestation in Queensland, Australia, delivered from 2000 to 2018. Rates of stillbirth, neonatal death, and severe neonatal morbidity were calculated for <3rd, 3rd to <10th, 10th to <25th, 25th to <90th, and ≥90th birthweight centiles. The composite risk of mortality with expectant management for an additional week in utero was compared with rates of neonatal mortality and severe neonatal morbidity.

    RESULTS: Of 948,895 singleton, term nonanomalous births, 813,077 occurred at 37+0 to 40+6 weeks' gestation. Rates of stillbirth increased with gestational age, with the highest rate observed in infants with birthweight below the third centile: 10.0 per 10,000 (95% confidence interval, 6.2-15.3) at 37+0 to 37+6 weeks, rising to 106.4 per 10,000 (95% confidence interval, 74.6-146.9) at 40+0 to 40+6 weeks' gestation. The rate of neonatal mortality was highest at 37+0 to 37+6 weeks for all birthweight centiles. The composite risk of expectant management rose sharply after 39+0 to 39+6 weeks, and was highest in infants with birthweight below the third centile (125.2/10,000; 95% confidence interval, 118.4-132.3) at 40+0 to 40+6 weeks' gestation. Balancing the risk of expectant management and delivery (neonatal mortality), the optimal timing of delivery for each birthweight centile was evaluated on the basis of relative risk differences. The rate of severe neonatal morbidity sharply decreased in the period between 37+0 to 37+6 and 38+0 to 38+6 weeks, particularly for infants with birthweight below the third centile.

    CONCLUSION: Our data suggest that the optimal time of birth is 37+0 to 37+6 weeks for infants with birthweight <3rd centile and 38+0 to 38+6 weeks' gestation for those with birthweight between the 3rd and 10th centile and >90th centile. For all other birthweight centiles, birth from 39+0 weeks is associated with the best outcomes. However, large numbers of planned births are required to prevent a single excess death. The healthcare costs and acceptability to women of potential universal policies of planned birth need to be carefully considered.

    Matched MeSH terms: Infant; Infant Mortality; Infant, Newborn
  5. Hamid NA, Hong JGS, Hamdan M, Vallikkannu N, Adlan AS, Tan PC
    Am J Obstet Gynecol, 2023 Oct;229(4):443.e1-443.e9.
    PMID: 37207931 DOI: 10.1016/j.ajog.2023.04.049
    BACKGROUND: A prolonged second stage of labor increases the risk of severe perineal laceration, postpartum hemorrhage, operative delivery, and poor Apgar score. The second stage is longer in nulliparas. Maternal pushing during the second stage of labor is an important contributor to the involuntary expulsive force developed by uterine contraction to deliver the fetus. Preliminary data indicate that visual biofeedback during the active second stage hastens birth.

    OBJECTIVE: This study aimed to evaluate if visual feedback focusing on the perineum reduced the length of the active second stage of labor in comparison with the control.

    STUDY DESIGN: A randomized controlled trial was conducted in the University Malaya Medical Centre from December 2021 to August 2022. Nulliparous women about to commence the active second stage, at term, with singleton gestation, reassuring fetal status, and no contraindication for vaginal delivery were randomized to live viewing of the maternal introitus (intervention) or maternal face (sham/placebo control) as visual biofeedback during their pushing. A video camera Bluetooth-linked to a tablet computer display screen was used; in the intervention arm, the camera was focused on the introitus, and in the control arm, on the maternal face. Participants were instructed to watch the display screen during their pushing. The primary outcomes were the intervention-to-delivery interval and maternal satisfaction with the pushing experience assessed using a 0-to-10 visual numerical rating scale. Secondary outcomes included mode of delivery, perineal injury, delivery blood loss, birthweight, umbilical cord arterial blood pH and base excess at birth, Apgar score at 1 and 5 minutes, and neonatal intensive care unit admission. Data were analyzed with the t test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate.

    RESULTS: A total of 230 women were randomized (115 to intervention and 115 to control arm). The active second stage duration (intervention-to-delivery interval) was a median (interquartile range) of 16 (11-23) and 17 (12-31) minutes (P=.289), and maternal satisfaction with the pushing experience was 9 (8-10) and 7 (6-7) (P

    Matched MeSH terms: Infant, Newborn
  6. Rogers IM
    J Pediatr Surg, 2023 Oct;58(10):2066-2067.
    PMID: 36907772 DOI: 10.1016/j.jpedsurg.2023.01.064
    Matched MeSH terms: Infant
  7. How KN, Chang HW, Lai OM
    J Cosmet Dermatol, 2023 Oct;22(10):2746-2754.
    PMID: 37143441 DOI: 10.1111/jocd.15793
    BACKGROUND: Little is known about antioxidant efficacy of topical vitamin E on atopic dermatitis (AD) due to lack of controlled clinical studies.

    AIM: The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.

    METHODS: We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).

    RESULTS: Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p Infant's Dermatitis Quality of Life Index and Children's Dermatology Life Quality Index were found to improve significantly compared to baseline (p 

    Matched MeSH terms: Infant
  8. Youn YA, Kim SY, Cho SJ, Chang YS, Miyake F, Kusuda S, et al.
    Sci Rep, 2023 Sep 20;13(1):15602.
    PMID: 37730731 DOI: 10.1038/s41598-023-42432-3
    Advances in perinatal care have led to the increased survival of preterm infants with subsequent neonatal morbidities, such as retinopathy of prematurity (ROP). This study aims to compare the differences of neonatal healthcare systems, resources, and clinical practice concerning ROP in Asia with review of current literature. An on-line survey at the institutional level was sent to the directors of 336 neonatal intensive care units (NICU) in 8 collaborating national neonatal networks through the Asian Neonatal Network Collaboration (AsianNeo). ROP screening was performed in infants born at infants born at infants with birth weight
    Matched MeSH terms: Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight
  9. Aburezq M, Alahmad A, Alsafi R, Al-Tawari A, Ramadan D, Shafik M, et al.
    Orphanet J Rare Dis, 2023 Sep 05;18(1):271.
    PMID: 37670342 DOI: 10.1186/s13023-023-02888-y
    BACKGROUND: Biotin-thiamine-responsive basal ganglia disease (BTBGD) is a rare autosomal recessive neurometabolic disorder that is caused by biallelic pathogenic SLC19A3 variants and is characterized by subacute encephalopathy associated with confusion, convulsions, dysphagia, dysarthria, or other neurological manifestations.

    METHODS: A retrospective review of the data registry in Kuwait Medical Genetics Center for all cases diagnosed clinically and radiographically and confirmed genetically with BTBGD.

    RESULTS: Twenty one cases from 13 different families were diagnosed with BTBGD in Kuwait. Most cases (86%) presented with confusion, dystonia, convulsions, or dysarthria, while three individuals were diagnosed pre-symptomatically during familial targeted genetic screening. Symptoms resolved completely within 2-week of treatment in two-thirds of the symptomatic cases but progressed in six of them to a variety of severe symptoms including severe cogwheel rigidity, dystonia and quadriparesis due to delayed presentation and management. Neuroradiological findings of the symptomatic cases revealed bilateral central changes in the basal ganglia. Two novel homozygous missense SLC19A3 variants were detected in a Kuwaiti and a Jordanian individuals, in addition to the previously reported Saudi founder homozygous variant, c.1264A > G; p.(Thr422Ala) in the remaining cases. Age of diagnosis ranged from newborn to 32 years, with a median age of 2-3 years. All cases are still alive receiving high doses of biotin and thiamine.

    CONCLUSION: This is the first study reporting the phenotypic and genotypic spectrum of 21 individuals with BTBGD in Kuwait and describing two novel SLC19A3 variants. BTBGD is a treatable neurometabolic disease that requires early recognition and treatment initiation. This study highlights the importance of performing targeted molecular testing of the founder variant in patients presenting with acute encephalopathy in the region.

    Matched MeSH terms: Infant, Newborn
  10. Op den Brouw B, Fernandez-Rojo MA, Charlton T, Fry BG, Ikonomopoulou MP
    Toxins (Basel), 2023 Sep 04;15(9).
    PMID: 37755975 DOI: 10.3390/toxins15090549
    Snake venoms constitute a complex, rapidly evolving trait, whose composition varies between and within populations depending on geographical location, age and preys (diets). These factors have determined the adaptive evolution for predatory success and link venom heterogeneity with prey specificity. Moreover, understanding the evolutionary drivers of animal venoms has streamlined the biodiscovery of venom-derived compounds as drug candidates in biomedicine and biotechnology. The king cobra (Ophiophagus hannah; Cantor, 1836) is distributed in diverse habitats, forming independent populations, which confer differing scale markings, including between hatchlings and adults. Furthermore, king cobra venoms possess unique cytotoxic properties that are used as a defensive trait, but their toxins may also have utility as promising anticancer-agent candidates. However, the impact of geographical distribution and age on these potential venom applications has been typically neglected. In this study, we hypothesised that ontogenetic venom variation accompanies the morphological distinction between hatchlings and adults. We used non-transformed neonatal foreskin (NFF) fibroblasts to examine and compare the variability of venom cytotoxicity between adult captive breeding pairs from Malaysian and Chinese lineages, along with that of their progeny upon hatching. In parallel, we assessed the anticancer potential of these venoms in human-melanoma-patient-derived cells (MM96L). We found that in a geographical distribution and gender-independent manner, venoms from hatchlings were significantly less cytotoxic than those from adults (NFF; ~Log EC50: 0.5-0.6 vs. 0.2-0.35 mg/mL). This is consistent with neonates occupying a semifossorial habitat, while adults inhabit more above-ground habitats and are therefore more conspicuous to potential predators. We also observed that Malaysian venoms exhibited a slightly higher cytotoxicity than those from the Chinese cobra cohorts (NFF; Log EC50: 0.1-0.3 vs. 0.3-0.4 mg/mL), which is consistent with Malaysian king cobras being more strongly aposematically marked. These variations are therefore suggestive of differential anti-predator strategies associated with the occupation of distinct niches. However, all cobra venoms were similarly cytotoxic in both melanoma cells and fibroblasts, limiting their potential medical applications in their native forms.
    Matched MeSH terms: Infant, Newborn
  11. Low CX, Kok YQ, Loo XS, Ngim CF, Lim RZM, Quah SY
    Med J Malaysia, 2023 Sep;78(5):661-668.
    PMID: 37775495
    INTRODUCTION: Burn injuries incur not just significant morbidity but also long-term psychosocial impact. This study aims to identify the clinico-demographics of children hospitalised for burns and factors associated with prolonged hospitalisation.

    MATERIALS AND METHODS: Written medical records of burn patients admitted to the Sultanah Aminah Hospital paediatric surgical ward, from January 2016 to December 2018, were retrospectively reviewed. Details on the patients' socio-demographic background, burn injuries, management and outcomes were recorded and analysed with logistic regression.

    RESULTS AND CONCLUSION: Of the 255 children included in the study, the majority were males (62.7%), children aged between 1 to 3 years (43.1%), and of the Malay ethnic group (83.1%). The commonest injury mechanism was scalds burns (81.2%). Staphylococcus aureus remained the commonest organism cultured from paediatric burn wounds. Most patients (66.4%) were hospitalised for less than 1 week. A significant number of patients experienced complications from their injuries. Multivariate analysis showed burns affecting total body surface area > 10% (adjusted OR, 13.45 [95% CI 6.25 - 28.96]; p = < 0.001) and non-scald burns (adjusted OR, 2.70 [95% CI 1.12 - 6.50]; p = 0.027) were the two main factors associated with prolonged hospitalisation of more than 1 week. These findings describing the epidemiology and outcomes of paediatric burn cases in a tertiary centre in Malaysia may inform future practice. More importantly, the information may contribute to the identification of at-risk populations and advise the development of effective prevention strategies to reduce the incidence and morbidity associated with paediatric burns in this region.

    Matched MeSH terms: Infant
  12. Syed Mohd Hamdan SN, Rahmat RA, Abdul Razak F, Abd Kadir KA, Mohd Faizal Abdullah ER, Ibrahim N
    Leg Med (Tokyo), 2023 Sep;64:102275.
    PMID: 37229938 DOI: 10.1016/j.legalmed.2023.102275
    Sex estimation is crucial in biological profiling of skeletal human remains. Methods used for sex estimation in adults are less effective for sub-adults due to varied cranium patterns during the growth period. Hence, this study aimed to develop a sex estimation model for Malaysian sub-adults using craniometric measurements obtained through multi-slice computed tomography (MSCT). A total of 521 cranial MSCT dataset of sub-adult Malaysians (279 males, 242 females; 0-20 years old) were collected. Mimics software version 21.0 (Materialise, Leuven, Belgium) was used to construct three-dimensional (3D) models. A plane-to-plane (PTP) protocol was utilised to measure 14 selected craniometric parameters. Discriminant function analysis (DFA) and binary logistic regression (BLR) were used to statistically analyze the data. In this study, low level of sexual dimorphism was observed in cranium below 6 years old. The level was then increased with age. For sample validation data, the accuracy of DFA and BLR in estimating sex improved with age from 61.6% to 90.3%. All age groups except 0-2 and 3-6 showed high accuracy percentage (≥75%) when tested using DFA and BLR. DFA and BLR can be utilised to estimate sex for Malaysian sub-adult using MSCT craniometric measurements. However, BLR showed higher accuracy than DFA in sex estimation of sub-adults.
    Matched MeSH terms: Infant; Infant, Newborn
  13. Muhammed A, Shariff-Ghazali S, Md Said S, Hassan M, Lee K
    Birth, 2023 Sep;50(3):587-595.
    PMID: 36226886 DOI: 10.1111/birt.12681
    BACKGROUND: The majority of women in Sokoto, Nigeria prefer homebirths, but midwives are reluctant to provide care in the home setting. As such, many women continue to give birth at home alone or assisted by untrained attendants, which is associated with an increased risk for maternal and neonatal morbidity and mortality.

    METHODS: A randomized controlled trial was conducted among 226 midwives from 10 health care facilities. The intervention group received an educational program on home birth. A validated questionnaire that evaluated knowledge, attitudes, norms, perceived control, and intention to provide planned home birth care was given at baseline, immediately after the intervention, and at three-months follow-up. Data were analyzed using linear mixed-effect model statistics.

    RESULTS: Following the intervention, the intervention group demonstrated higher knowledge and more positive attitudes, norms, perceived control, and intention to provide planned home birth care compared with the control group (P  0.05).

    DISCUSSION: Educating midwives on planned home birth increases their willingness to provide planned home birth care. Health system administrators, policymakers, and researchers may use similar interventions to promote skilled home birth attendance by midwives. Increasing the number of midwives who are willing to attend planned home births provides women at low risk for medical complications with safer options for labor, delivery, and postpartum care.

    Matched MeSH terms: Infant, Newborn
  14. Al-Herz W, Ziyab AH, Adeli M, Al Farsi T, Al-Hammadi S, Al Kuwaiti AA, et al.
    Clin Immunol, 2023 Sep;254:109696.
    PMID: 37481010 DOI: 10.1016/j.clim.2023.109696
    AIMS: To understand the characteristics of combined immunodeficiency disorders that affect cellular and humoral immunity (CID) in the Arabian Peninsula.

    METHODS: Retrospective study of 236 patients with CID from the region were enrolled from 2004 to 2022.

    RESULTS: 236 patients were included with a majority being profound CID. Among patients with a family history of CID, the ages at onset and diagnosis, and the delay in diagnosis were lower compared to those with no family history of CID, but this did not affect time to transplant. HSCT was performed for 51.27% of the patients with median time from diagnosis to HSCT of 6.36 months. On multivariate analysis, patients who underwent early transplant had increased odds of having CD3 count ≤1000 cell/μl, diagnosed by screening or erythroderma.

    CONCLUSION: There is a delay in diagnosis and treatment of CID in our region. Establishing newborn screening programs and HSCT units in our region are the urgent need.

    Matched MeSH terms: Infant, Newborn
  15. Lilyasari O, Goo HW, Siripornpitak S, Abdul Latiff H, Ota H, Caro-Dominguez P
    Pediatr Radiol, 2023 Sep;53(10):2120-2133.
    PMID: 37202498 DOI: 10.1007/s00247-023-05660-3
    Anomalous pulmonary venous connections represent a heterogeneous group of congenital heart diseases in which a part or all pulmonary venous flow drains directly or indirectly into the right atrium. Clinically, anomalous pulmonary venous connections may be silent or have variable consequences, including neonatal cyanosis, volume overload and pulmonary arterial hypertension due to the left-to-right shunt. Anomalous pulmonary venous connections are frequently associated with other congenital cardiac defects and their accurate diagnosis is crucial for treatment planning. Therefore, multimodality diagnostic imaging, comprising a combination (but not all) of echocardiography, cardiac catheterization, cardiothoracic computed tomography and cardiac magnetic resonance imaging, helps identify potential blind spots relevant to each imaging modality before treatment and achieve optimal management and monitoring. For the same reasons, diagnostic imaging evaluation using a multimodality fashion should be used after treatment. Finally, those interpreting the images should be familiar with the various surgical approaches used to repair anomalous pulmonary venous connections and the common postoperative complications.
    Matched MeSH terms: Infant, Newborn
  16. Baba A, Webbe J, Butcher NJ, Rodrigues C, Stallwood E, Goren K, et al.
    Pediatrics, 2023 Sep 01;152(3).
    PMID: 37641881 DOI: 10.1542/peds.2022-060751
    OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.

    METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.

    RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.

    CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.

    Matched MeSH terms: Infant, Newborn
  17. Webbe J, Baba A, Butcher NJ, Rodrigues C, Stallwood E, Goren K, et al.
    Pediatrics, 2023 Sep 01;152(3).
    PMID: 37641894 DOI: 10.1542/peds.2022-060765
    BACKGROUND AND OBJECTIVES: There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications.

    METHODS: Neonatal trials including >100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports.

    RESULTS: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: "survival," "short-term neonatal complications," and "long-term developmental outcomes" depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting.

    CONCLUSIONS: We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.

    Matched MeSH terms: Infant, Newborn
  18. Bavanandan S, Keita N
    Semin Nephrol, 2023 Sep;43(5):151468.
    PMID: 38403525 DOI: 10.1016/j.semnephrol.2023.151468
    Urinary tract infections are the most common bacterial infections encountered by health care professionals. In women, the lifetime incidence of urinary tract infections may be up to 40% to 50%, of whom a further 40% may have recurrent infections. Urinary tract infections are associated with significant morbidity and potential mortality-they may be complicated by frequent recurrences, kidney damage, sepsis, and preterm birth, as well as collateral damage of antimicrobial use, which includes Clostridium difficile colitis and selection of drug-resistant organisms. There are personal costs such as reduced quality of life in patients affected by recurrent urinary tract infections, and societal impacts resulting from absenteeism and health care costs. In this review, we discuss the definitions and classifications, pathogenesis, and current principles of management and prevention of urinary tract infections. Semin Nephrol 43:x-xx © 2023 Elsevier Inc. All rights reserved.
    Matched MeSH terms: Infant, Newborn
  19. Hasani WSR, Muhamad NA, Hanis TM, Maamor NH, Chen XW, Omar MA, et al.
    BMC Public Health, 2023 Aug 16;23(1):1561.
    PMID: 37587427 DOI: 10.1186/s12889-023-16466-1
    BACKGROUND: Cardiovascular disease (CVD) is a significant cause of premature mortality worldwide, with a growing burden in recent years. Despite this, there is a lack of comprehensive meta-analyses that quantify the extent of premature CVD mortality. Study addressed this gap by estimating the pooled age-standardized mortality rate (ASMR) of premature CVD mortality.

    METHODS: We conducted a systematic review of published CVD mortality studies that reported ASMR as an indicator for premature mortality measurement. All English articles published as of October 2022 were searched in four electronic databases: PubMed, Scopus, Web of Science (WoS), and the Cochrane Central Register of Controlled Trials (CENTRAL). We computed pooled estimates of ASMR using random-effects meta-analysis. We assessed heterogeneity from the selected studies using the I2 statistic. Subgroup analyses and meta regression analysis was performed based on sex, main CVD types, income country level, study time and age group. The analysis was performed using R software with the "meta" and "metafor" packages.

    RESULTS: A total of 15 studies met the inclusion criteria. The estimated global ASMR for premature mortality from total CVD was 96.04 per 100,000 people (95% CI: 67.18, 137.31). Subgroup analysis by specific CVD types revealed a higher ASMR for ischemic heart disease (ASMR = 15.57, 95% CI: 11.27, 21.5) compared to stroke (ASMR = 12.36, 95% CI: 8.09, 18.91). Sex-specific differences were also observed, with higher ASMRs for males (37.50, 95% CI: 23.69, 59.37) than females (15.75, 95% CI: 9.61, 25.81). Middle-income countries had a significantly higher ASMR (90.58, 95% CI: 56.40, 145.48) compared to high-income countries (21.42, 95% CI: 15.63, 29.37). Stratifying by age group indicated that the age groups of 20-64 years and 30-74 years had a higher ASMR than the age group of 0-74 years. Our multivariable meta-regression model suggested significant differences in the adjusted ASMR estimates for all covariates except study time.

    CONCLUSIONS: This meta-analysis synthesized a comprehensive estimate of the worldwide burden of premature CVD mortality. Our findings underscore the continued burden of premature CVD mortality, particularly in middle-income countries. Addressing this issue requires targeted interventions to mitigate the high risk of premature CVD mortality in these vulnerable populations.

    Matched MeSH terms: Infant; Infant, Newborn
  20. Tang BH, Zhang JY, Allegaert K, Hao GX, Yao BF, Leroux S, et al.
    Clin Pharmacokinet, 2023 Aug;62(8):1105-1116.
    PMID: 37300630 DOI: 10.1007/s40262-023-01265-z
    BACKGROUND AND OBJECTIVE: High variability in vancomycin exposure in neonates requires advanced individualized dosing regimens. Achieving steady-state trough concentration (C0) and steady-state area-under-curve (AUC0-24) targets is important to optimize treatment. The objective was to evaluate whether machine learning (ML) can be used to predict these treatment targets to calculate optimal individual dosing regimens under intermittent administration conditions.

    METHODS: C0 were retrieved from a large neonatal vancomycin dataset. Individual estimates of AUC0-24 were obtained from Bayesian post hoc estimation. Various ML algorithms were used for model building to C0 and AUC0-24. An external dataset was used for predictive performance evaluation.

    RESULTS: Before starting treatment, C0 can be predicted a priori using the Catboost-based C0-ML model combined with dosing regimen and nine covariates. External validation results showed a 42.5% improvement in prediction accuracy by using the ML model compared with the population pharmacokinetic model. The virtual trial showed that using the ML optimized dose; 80.3% of the virtual neonates achieved the pharmacodynamic target (C0 in the range of 10-20 mg/L), much higher than the international standard dose (37.7-61.5%). Once therapeutic drug monitoring (TDM) measurements (C0) in patients have been obtained, AUC0-24 can be further predicted using the Catboost-based AUC-ML model combined with C0 and nine covariates. External validation results showed that the AUC-ML model can achieve an prediction accuracy of 80.3%.

    CONCLUSION: C0-based and AUC0-24-based ML models were developed accurately and precisely. These can be used for individual dose recommendations of vancomycin in neonates before treatment and dose revision after the first TDM result is obtained, respectively.

    Matched MeSH terms: Infant, Newborn
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