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1.
Trials ; 22(1): 637, 2021 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-34535164

RESUMO

BACKGROUND: Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care unit (NICU) are limited to pacifier use or bottle-feeding exercises. Skin contact has been shown to be beneficial to start and maintain lactation and provide preterm infants with the opportunity to suck on the mother's breast, which may promote further development of the preterm infant's suckling patterns. The objective of this study is to compare and evaluate the effects of skin contact combined with breastfeeding (suck on the mother's empty breast) as compared to the routine pacifier suckling training model in achieving full oral feeding for infants whose gestational age are ≤ 30 weeks. METHODS: This is a single-center, randomized controlled clinical trial conducted in the NICU and designed according to the SPIRIT Statement. The subjects included in the study are premature infants born between April 2020 and July 2021 with a gestational age of ≤30 weeks, birth weight of <1500 g, admission age of <72 h, and absence of congenital malformations. Those with oxygenation indices of >40 and those born to mothers with poor verbal communication skills will be excluded. A sample of 148 infants is needed. The infants will be randomized to the intervention (skin contact combined with mother's breastfeeding model) or control group (routine pacifier sucking training model). The primary outcome is the time required to achieve full oral feeding. The secondary outcomes are the breastfeeding abilities of preterm infants as assessed by the Preterm Infant Breastfeeding Behavior Scale (PIBBS), breastfeeding rates at 3 and 6 months corrected gestational age, complication rates, duration of oxygen requirement, days of hospital stay, and satisfaction of parents. DISCUSSION: This paper describes the first single-center, open-label, randomized clinical trial on this topic and will provide crucial information to support the implementation of skin contact combined with the breastfeeding model in the NICU setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT04283682. Registered on 8 February 2020.


Assuntos
Aleitamento Materno , Mães , Feminino , Humanos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
J Pediatr ; 2021 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-34461063

RESUMO

OBJECTIVE: To provide national-level antibiotic use data from Chinese neonatal intensive care units to inform future antimicrobial stewardship using a large contemporary cohort of preterm infants in China. STUDY DESIGN: This retrospective cohort study enrolled all infants less than 340/7 weeks of gestation admitted to 25 tertiary neonatal intensive care units across China between May 1, 2015, and April 30, 2018. The antibiotic use rate (AUR) was defined as the number of days an infant was prescribed with 1 or more antibiotics divided by the total length of hospital stay. RESULTS: Among 24 597 eligible infants, 21 736 (88.4%) infants received antibiotics. The median AUR was 441 per 1000 patient-days (IQR, 242-692 per 1000 patient-days). The median duration of each antibiotic course was 9 days (IQR, 6-14 days). Overall, 64.6% infants received broad-spectrum antibiotics, with a median broad-spectrum AUR of 250 per 1000 patient-days (IQR, 0-500 per 1000 patient-days), accounting for 70.7% of all antibiotic use days. Overall, 68.7% of all antibiotic use occurred among infants without infection-related morbidities, with a median duration of 8 days (IQR, 6-13 days) for each course. Only 22.9% episodes of culture-negative sepsis were prescribed with antibiotics for 7 or fewer days, and 34.7% were treated with antibiotics for more than 14 days. For early antibiotic use, the median duration of antibiotic therapy within 7 days after birth was 7 days (IQR, 4-7 days). CONCLUSIONS: A high AUR among infants without infections, prolonged antibiotic durations, and excessive use of broad-spectrum antibiotics were the main problems of antibiotic use in Chinese neonatal intensive care units and should be high-impact focuses for future stewardship interventions.

3.
Epilepsy Behav ; 123: 108248, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34455296

RESUMO

OBJECTIVES: To describe the inpatient medical cost during hospitalization in children with status epilepticus (SE) and identify factors associated with the cost by a nationwide, multicenter study in China. MATERIALS & METHODS: We retrospectively identified pediatric inpatients with SE form Hospital Information System (HIS) of 44 hospitals in 27 provinces in China between 2013 and 2015. Inpatient medical cost and factors associated with the cost were analyzed. RESULTS: A total of 4041 children diagnosed with SE with inpatient medical cost were enrolled in the present study. The median age at admission was 2.9 (range 0.1-18) years, and 2271 patients were male (56.2%). The median inpatient medical cost of children with SE was $1175.5 (665.1-2320.6). The median inpatient medical cost was $3865.6 (1837.4-8210.4) in children with SRSE and $1048.6 (619.8-1865.4) in those with N-SRSE (p < 0.0001). Children with length of hospital stay (LOS) > 7 showed a much higher inpatient medical cost than those with LOS ≤ 7 day ($2300.7 vs. $767.2, p < 0.0001). Regarding different etiologies, children with acute symptomatic etiology showed the highest median inpatient medical cost of $1681.1 (901.0-3699.6), in which children with central nervous system (CNS) infection reported $2606.0 (1380.0-5016.1) and prolonged febrile seizures (PFS) reported $909.8 (649.3-1322.0). Additionally, children with idiopathic/cryptogenic etiology reported a medical cost of $923.2 (548.9-1534.5). Multiple linear regression analysis of cost-driving factors revealed LOS > 7, examinations, treatment equipment and procedures, and treatment medicines were independently associated with a higher inpatient medical cost (R2 = 60.91). In addition, PFS and idiopathic/cryptogenic epilepsy etiology were independently associated with a lower cost. CONCLUSIONS: SE in children was a cost intensive disease in China with a median inpatient medical cost of $1175.5. LOS, etiology and examinations, treatment equipment and procedures, and treatment medicines were significantly associated with inpatient medical cost.

4.
Artigo em Inglês | MEDLINE | ID: mdl-34165218

RESUMO

BACKGROUND: Maternal vitamin D status during pregnancy has been linked with the risk of atopic dermatitis (AD) in children, while the results were inconsistent. The objective of this study was to assess the potential association. METHODS: Serum 25-hydroxyvitamin D (25(OH)D) levels were measured in pregnant women from the birth cohort MKFOAD. Infant AD was diagnosed according to Williams' criteria. Multivariate logistic regression model was used to examine the association of maternal serum 25(OH)D levels in the first, second, and third trimester of gestation with the risk of infant AD at first year of age. RESULTS: In total, 121 (26.5%) of 456 infants developed AD prior to 1 year of age. In general, higher maternal serum 25(OH)D levels throughout pregnancy were associated with increased risks of AD in infants prior to 1 year of age in multivariate logistic regression models, with borderline statistical significance in the first (per ln unit increase: adjusted OR = 1.93, 95% CI: 0.96, 3.88) and second (per ln unit increase: adjusted OR = 1.72, 95% CI: 0.93, 3.19) trimester. Multivariate logistic regression models using categorical variables of maternal 25(OH)D levels by tertiles showed similar results: Infants born to mothers with serum 25(OH)D levels in the highest tertile had higher risk of AD than those with 25(OH)D in the lowest tertile. CONCLUSIONS: The present study found some evidence supporting that higher maternal 25(OH)D levels during pregnancy increased the risk of infant AD. However, the clinical implication of the findings should be limited for those with blood levels over the recommendations.

6.
JAMA Netw Open ; 4(6): e2113197, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-34137828

RESUMO

Importance: A significant proportion of very preterm infants (<32 weeks' gestation) are discharged against medical advice (DAMA) from neonatal intensive care units in China. There is minimal information available on the potential outcomes of providing complete care before discharge in these infants. Objective: To describe potential neonatal outcomes of DAMA in very preterm infants if they receive complete care based on estimates derived from a group of propensity score-matched infants who are not DAMA. Design, Setting, and Participants: This cohort study enrolled all infants born at between 24 and 31 weeks' gestation from May 1, 2015, to April 30, 2018, and admitted to 25 tertiary neonatal intensive care units across China within 7 days of birth. A multilevel mixed-effects logistic regression model was constructed to estimate the propensity score for the likelihood of DAMA for each infant. Infants who were not DAMA were then matched to DAMA infants with the closest propensity score on a 1:1 ratio by using a nearest neighbor greedy matching algorithm without replacement. Incidences of neonatal outcomes were then calculated among the matched non-DAMA infants to simulate the outcomes of DAMA infants. Statistical analyses were performed from August 16, 2020, to September 26, 2020. Exposures: Discharge against medical advice, which was defined as termination of treatment and discharge before the treating physicians recommended discharge. Main Outcomes and Measures: Survival and survival without major morbidity. Results: The study enrolled a total of 14 083 infants (8141 boys [57.8%]) with a median gestational age of 30.1 weeks (interquartile range [IQR], 29.0-31.1 weeks) and a median birth weight of 1400 g (IQR, 1170-1600 g). Overall, 1876 of 14 083 very preterm infants (13.3%; 95% CI, 12.8%-13.9%) were DAMA, of whom 1367 of 1876 (72.9%; 95% CI, 70.8%-74.8%) required intensive care on discharge. A total of 1473 DAMA infants were successfully matched to 1473 non-DAMA infants. Overall, 1211 of 1473 matched non-DAMA infants (82.2%; 95% CI, 80.2%-84.1%) survived to discharge. The survival rates were 68.3% (95% CI, 62.4%-73.7%) for infants at 26 to 27 weeks' gestation, 84.1% (95% CI, 80.7%-87.0%) for infants 28 to 29 weeks' gestation, and 92.4% (95% CI, 90.0%-94.2%) for infants at 30 to 31 weeks' gestation. A total of 872 of 1473 matched non-DAMA infants (59.2%; 95% CI, 56.7%-61.7%) survived without any major morbidity. Conclusions and Relevance: The results of this cohort study suggest that very preterm infants who are DAMA from neonatal intensive care units may have intact survival if complete care is provided. Efforts to reduce DAMA may be associated with improved outcomes of very preterm infants in China.

7.
Ecotoxicol Environ Saf ; 220: 112397, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-34116334

RESUMO

BACKGROUND: Decline in pulmonary function contributes to increasing cardiovascular disease (CVD) risk. Although adverse effects of short-term exposure to fine particulate matter (PM2.5) on pulmonary function have been recognized in healthy people or patients with respiratory disease, these results were not well illustrated among people with elevated CVD risk. MATERIALS AND METHODS: A panel study was conducted in three Chinese cities with three repeated visits among populations at intermediate to high-risk of CVD, defined as treated hypertension patients or those with blood pressure ≥ 130/80 mmHg, who met any of the three conditions including abdominal obesity, dyslipidemia, and diabetes mellitus. Individualized PM2.5 exposure and pulmonary function were measured during each seasonal visit. Linear mixed-effect models were applied to analyze the associations of PM2.5 concentrations with pulmonary function indicators, including forced expiratory volume in 1 s (FEV1), FEV1/forced vital capacity (FVC), maximal mid-expiratory flow (MMF), and peak expiratory flow (PEF). RESULTS: Short-term PM2.5 exposure was significantly associated with decreased pulmonary function and an increment of 10 µg/m3 in PM2.5 concentrations during lag 12-24 hour was associated with declines of 41.7 ml/s (95% confidence interval [CI]: 7.7-75.7), 0.35% (95% CI: 0.01, 0.69), and 20.9 ml/s (95% CI: 0.5-41.3) for PEF, FEV1/FVC, and MMF, respectively. Results from stratified and sensitivity analyses were generally similar with the overall findings, while the adverse effects of PM2.5 on pulmonary functions were more pronounced in those who were physically inactive. CONCLUSIONS: This study first identified short-term exposure to PM2.5 was associated with impaired pulmonary function and physical activity might attenuate the adverse effects of PM2.5 among populations at intermediate to high-risk of CVD. These findings provide new robust evidence on health effects of air pollution and call for effective prevention measures among people at CVD risk.


Assuntos
Poluentes Atmosféricos/efeitos adversos , Poluição do Ar/efeitos adversos , Doenças Cardiovasculares/fisiopatologia , Exposição Ambiental/efeitos adversos , Pulmão/efeitos dos fármacos , Material Particulado/efeitos adversos , Testes de Função Respiratória , Adulto , Poluentes Atmosféricos/análise , Poluição do Ar/análise , Pressão Sanguínea , Doenças Cardiovasculares/induzido quimicamente , China , Cidades , Exposição Ambiental/análise , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Material Particulado/análise , Fatores de Risco , Capacidade Vital
8.
Int J Infect Dis ; 107: 62-68, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33878461

RESUMO

OBJECTIVES: The treatment of acute herpangina is inconsistent. We aim to evaluate the effectiveness and safety of interferon α-2b spray versus Ribavirin for this disease. METHODS: A randomized, controlled trial was conducted in eight hospitals in China between 2016 and 2018. 668 patients (1-7 years old) were randomized into an experimental group (treated with Interferon α-2b spray) or control group (received Ribavirin Aerosol). Body temperature returning to normal within 72 h and remaining so for 24 h was the primary outcome; release of oral herpes and adverse events were the secondary outcomes. RESULTS: (1) The average age of onset was 2.5 years old. (2) After 72 h treatment, body temperature of 98.5% patients in experimental group and 94.3% in control group returned to normal and remained so for 24 h (P = 0.004). The differences were greater at 48 h treatment (95.2% vs. 85.9%, P < 0.001) and at 24 h (77.5% vs. 66.5%, P = 0.001). (3) The rate of improved oral herpes in the experimental group was higher than that in control group (46.7% vs.37.1%, P = 0.011). No adverse reaction occurred. CONCLUSIONS: Local application of recombinant interferon α-2b spray showed better efficacy for acute herpangina in children. It was safe for use.


Assuntos
Antivirais/administração & dosagem , Herpangina/tratamento farmacológico , Interferon alfa-2/administração & dosagem , Antivirais/efeitos adversos , Temperatura Corporal , Criança , Pré-Escolar , China , Método Duplo-Cego , Feminino , Febre/tratamento farmacológico , Humanos , Lactente , Interferon alfa-2/efeitos adversos , Masculino , Sprays Orais , Úlceras Orais/tratamento farmacológico , Ribavirina/administração & dosagem
9.
Autism ; 25(7): 1872-1884, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33845648

RESUMO

LAY ABSTRACT: The Autism Spectrum Rating Scale is a behavioural rating scale completed by parents and teachers that is useful for identifying children with an autism spectrum disorder. The development of a modified Autism Spectrum Rating Scale suitable for use in China is important for the identification of children in China with an autism spectrum disorder. In this study, we examined the Modified Chinese Autism Spectrum Rating Scale using a statistical technique known as Rasch analysis. Rasch analysis tests whether the questionnaire meets the standards for modern scientific measurement. We used Rasch analysis to examine data from 2013 children in China including 420 diagnosed with an autism spectrum disorder who had been rated by a parent or grandparent. After removing a small number of items (questions), the Modified Chinese Autism Spectrum Rating Scale met the stringent criteria for Rasch measurement. The availability of a reliable and precise tool for assessing behaviours characteristic of an autism spectrum disorder in Chinese children will improve the identification and diagnosis of autism spectrum disorder in China, thus enabling better provision of support services.


Assuntos
Transtorno do Espectro Autista , Transtorno Autístico , Transtorno do Espectro Autista/diagnóstico , Criança , China , Humanos , Pais , Psicometria , Reprodutibilidade dos Testes
10.
Eur J Clin Nutr ; 2021 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-33790398

RESUMO

BACKGROUND/OBJECTIVE: To investigate impacts of early postnatal macronutrient intakes on growth and body composition of preterm infants within the first 6 months. SUBJECTS/METHODS: One hundred and thirty-three very preterm (VPT) and/or very low birth weight (VLBW) infants were consecutively included. Enteral and parenteral macronutrient intakes during the first 28 days were recorded and average daily intakes were calculated. Growth was measured at birth, term age, and 6 months of corrected age (CA). Body composition was examined by air displacement plethysmograph at term age and 6 months of CA. Associations of nutrient intakes with growth and body composition over time were analyzed using generalized estimating equation. RESULTS: After adjusting for covariates, higher daily protein, lipid, and energy intake during the first 28 days was associated with higher weight at term age for every 1 g/kg/day increment of protein and lipid intake, and every 10 kcal/kg/day increment of energy intake was associated with 0.50 (95% CI 0.04, 0.96), 0.29 (95% CI 0.07, 0.51), and 0.27 (95% CI 0.10, 0.44) higher weight z-score, respectively. Higher protein intake was associated with lower z-score of fat mass (FM, ß = -1.88, 95% CI -3.53, -0.23) and percentage of body fat (PBF, ß = -2.18, 95% CI -3.98, -0.39) at 6 months of CA, but higher lipid and carbohydrate intake was associated with higher FM and PBF z-scores at 6 months of CA. CONCLUSIONS: Macronutrient intakes during the first month of life have impacts on growth and body composition before 6 months of age. Higher daily protein intake is associated with a better growth and healthier body composition for VPT/VLBW infants.

11.
Ital J Pediatr ; 47(1): 66, 2021 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-33726805

RESUMO

BACKGROUND: Early postanal growth of preterm infants has many effects on early and late health. However, evidence on growth pattern in Chinese preterm infant population during early life is insufficient. This study aims to describe the growth trajectory, catch-up growth, and risk of overweight of preterm infants during the first 2 years of life in a Chinese community population. METHODS: All preterm infants (n = 10,624) received routine childcare in one primary maternal and child healthcare network in 8 years were included. Body weight and length/height at corrected age (CA) 40 weeks, CA 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months were extracted and converted to z-scores based on the World Health Organization (WHO) standards. According to the intrauterine growth status, infants were divided into small for gestational age (SGA), appropriate for gestational age (AGA), and large for gestational age (LGA) infants. Changes of z-score were used to describe the growth velocity. Generalized estimating equation (GEE) model was used to analyze growth trajectory trends over time. RESULTS: Body weight and length/height were overall above the WHO standards during the first 2 years of life. Z-score increased significantly by 0.08 (95% CI: 0.06-0.10) in weight and 0.07 (95% CI: 0.04-0.09) in length/height from CA 40 weeks to 3 months and then levelled off until CA 24 months after adjustment. Almost 90% of AGA and LGA infants achieved growth targets (≥25th percentile of WHO standards), and over 85% of SGA infants achieved catch-up growth (≥10th percentile of WHO standards) before CA 24 months. However, the risk of overweight appeared during this period, with the proportion of infants with the risk of overweight being at the peak at CA 3 months (25.6% of all preterm infants and 39.4% of LGA infants). Growth trajectories of SGA showed increasing trends, but those of LGA showed decreasing trends during the first 2 years. CONCLUSIONS: Body weight and length/height of preterm infants are above the WHO standards in the Chinese community population during the first 2 years of life. Catch-up growth is accompanied by risk of overweight as early as CA 3 months. (349 words).


Assuntos
Recém-Nascido Prematuro/crescimento & desenvolvimento , Sobrepeso , Antropometria , China , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional/crescimento & desenvolvimento , Masculino , Fatores de Risco
12.
Chem Commun (Camb) ; 57(27): 3375-3378, 2021 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-33683223

RESUMO

Low viscosity photo-curable benzoxazines (BZs) are designed and synthesized for use in stereolithography 3D printing. An initial investigation shows that the thermally polymerized polybenzoxazines (PBZs) have remarkably high Tg (264 °C) and flexural modulus (4.91 GPa) values. Subsequently, the formulated photoprintable resins are employed for use in high-resolution projection micro-stereolithography (PµSL) printing. Complex PBZ 3D structures can be achieved from the as-printed objects after they are thermally treated. These findings advance the design of BZ monomers for photopolymerization-based 3D printing and offer a method for the efficient fabrication of high-performance thermosets for various demanding engineering applications.

13.
Pediatr Int ; 63(7): 757-763, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33600060

RESUMO

BACKGROUND: We aimed to assess the efficacy of different initial intravenous immunoglobulin (IVIG) regimens in Kawasaki disease (KD) patients to find more cost-effective therapy options. METHODS: A multicenter, open-label, blind-endpoint randomized controlled trial was conducted from January 2014 to December 2015. Patients with KD, within 10 days of illness, were randomly assigned to receive different IVIG regimens (Group A, 2 g/kg once; Group B, 1 g/kg for 2 consecutive days; Group C, 1 g/kg once) and aspirin 30mg/kg/d. Primary outcomes included hours to defervescence and development of coronary artery lesions during the study period. Major secondary outcomes included total fever days, total dose of IVIG, changes of laboratory data, length of stay, and hospitalization expenses. (ClinicalTrials.gov: NCT02439996). RESULTS: A total of 404 patients underwent randomization. No difference was found in the outcomes of defervescence among three groups at 6, 12, 24, and 36 hours after completion of initial IVIG infusion. There were no differences in the incidence of coronary artery lesions during the study period (at week 2, month 1, month 3, and month 6 of illness), changes of laboratory data, total fever days, and length of stay. Group C patients had the lowest total dose of IVIG (mean: 1.2 vs 2.2 vs 2.1 g/kg; P < 0.001) and hospitalization expenses (mean: 8443.8 vs 10798.4 vs 11011.4 Chinese Yuan; P < 0.001) than other two groups. CONCLUSIONS: A single dose of 1g/kg IVIG is a low-cost treatment with the same efficacy as 2 g/kg IVIG and can be an option for the initial therapy of KD patients.


Assuntos
Imunoglobulinas Intravenosas , Síndrome de Linfonodos Mucocutâneos , Aspirina , Febre , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Lactente , Síndrome de Linfonodos Mucocutâneos/tratamento farmacológico
14.
Clin Pharmacol Drug Dev ; 10(5): 521-534, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33400845

RESUMO

Savolitinib (AZD6094, HMPL-504, volitinib) is an oral, bioavailable, selective MET-tyrosine kinase inhibitor. This randomized, double-blind, 3-way, crossover phase 1 study of savolitinib versus moxifloxacin (positive control) and placebo-evaluated effects on the QT interval after a single savolitinib dose. Healthy non-Japanese men were randomized to 1 of 6 treatment sequences, receiving single doses of savolitinib 600 mg, moxifloxacin 400 mg, and placebo. The primary end point was time-matched, placebo-adjusted change from baseline in the QT interval corrected for the time between corresponding points on 2 consecutive R waves on electrocardiogram (RR) by the Fridericia formula (ΔΔQTcF). Secondary end points included 12-lead electrocardiogram (ECG) variables, pharmacokinetics, and safety. All 3 treatment periods were completed by 44 of 45 participants (98%). Baseline demographics were balanced across treatment groups. After a single savolitinib 600-mg dose, the highest least-squares mean ΔΔQTcF of 12 milliseconds was observed 5 hours postdose. Upper limits of the 2-sided 90% confidence interval for ΔΔQTcF exceeded 10 milliseconds (the prespecified International Council for Harmonisation limit) 3-6 hours postsavolitinib but otherwise remained less than the threshold. Savolitinib showed no additional effect on PR, QRS, QT, or RR intervals. A positive ΔΔQTcF signal from the moxifloxacin group confirmed study validity. Savolitinib was well tolerated, with a low incidence of adverse events. In this thorough QT/QTc study, QTcF prolongation was observed with a single savolitinib 600-mg dose. ECG monitoring will be implemented in ongoing and future studies of savolitinib to assess the clinical relevance of the observed QT changes from this study.

15.
Bioanalysis ; 13(5): 295-361, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33511867

RESUMO

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

16.
Pediatr Allergy Immunol ; 32(1): 137-145, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32663346

RESUMO

BACKGROUND: Maternal folate status is linked with the risk of allergic disorders including atopic dermatitis (AD) in children, but findings remain inconclusive. We aim to assess the relationship between maternal folate status in early gestation and early-onset infant AD, based on a prospective mother-child cohort study. METHODS: Pregnant women were recruited at 12-14 weeks of gestation. Red blood cell folate (RBC folate) and serum folate concentrations were examined at enrollment. Periconceptional folic acid supplementation was investigated through a self-administered questionnaire. The primary outcome was AD incidence before 6 months of age, diagnosed according to Williams' criteria. Multivariate logistic regression was used to evaluate associations of maternal folate status with infant AD by adjusting parental and child covariates. RESULTS: In total, 107 (23.4%) of 458 infants developed AD before 6 months, with more male infants affected (P = .002). Higher maternal RBC folate levels (per 100 ng/mL) were associated with an increased risk of AD (adjusted odds ratio [aOR] 1.16, 95% confidence interval [CI] 1.04-1.31). An RBC folate level ≥620 ng/mL was associated with increased infant AD by 91% (aOR 1.91, 95% CI 1.09-3.36). However, associations were not observed for maternal serum folate at early gestation or periconceptional folic acid supplement intakes. CONCLUSIONS: We provide the first evidence that higher maternal RBC folate concentrations during early gestation are associated with increased early-onset infant AD. Our findings support the importance of maintaining appropriate folate levels during the periconceptional period to reduce the risk of AD in infants.

17.
Diabetes Care ; 44(1): 217-223, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33158950

RESUMO

OBJECTIVE: To investigate the association of folate and vitamin B12 in early pregnancy with gestational diabetes mellitus (GDM) risk. RESEARCH DESIGN AND METHODS: The data of this study were from a subcohort within the Shanghai Preconception Cohort Study. We included pregnancies with red blood cell (RBC) folate and vitamin B12 measurements at recruitment (between 9 and 13 gestational weeks) and those with three samples available for glucose measurements under an oral glucose tolerance test. GDM was diagnosed between 24 and 28 weeks' gestation. Odds ratio (OR) and 95% CI of having GDM was used to quantify the association. RESULTS: A total of 1,058 pregnant women were included, and GDM occurred in 180 (17.01%). RBC folate and vitamin B12 were significantly higher in pregnancies with GDM than those without GDM (P values were 0.045 and 0.002, respectively) and positively correlated with 1-h and 2-h serum glucose. Daily folic acid supplementation in early pregnancy increases the risk of GDM; OR (95% CI) was 1.73 (1.19-2.53) (P = 0.004). Compared with RBC folate <400 ng/mL, pregnancies with RBC folate ≥600 ng/mL were associated with ∼1.60-fold higher odds of GDM; the adjusted OR (95% CI) was 1.58 (1.03-2.41) (P = 0.033). A significant trend of risk effect on GDM risk across categories of RBC folate was observed (P trend = 0.021). Vitamin B12 was significantly associated with GDM risk (OR 1.14 per 100 pg/mL; P = 0.002). No significant association of serum folate and percentile ratio of RBC folate/vitamin B12 with GDM was observed. CONCLUSIONS: Higher maternal RBC folate and vitamin B12 levels in early pregnancy are significantly associated with GDM risk, while the balance of folate/vitamin B12 is not significantly associated with GDM.

18.
Artigo em Inglês | MEDLINE | ID: mdl-33171028

RESUMO

Objective: The objective was to evaluate the impact of different forms of iron including myoglobin, hemin and ferric chloride on the quality of chicken breast meat. Methods: Chicken breast muscles were subjected to 1, 2, 3 mg/mL of FeCl3, myoglobin and hemin treatment respectively, and the production of reactive oxygen species (ROS) and malondialdehyde (MDA), meat color, tenderness, water holding capacity and morphology of meat was evaluated. Results: Hemin was found to produce more ROS and induce greater extent of lipid oxidation than myoglobin and ferric chloride. However, it showed that hemin could significantly increase the redness and decrease the lightness of the muscle. Hemin was also shown to be prominent in improving water holding capacity of meat, maintaining a relatively higher level of the immobilized water from low-field NMR measurements. Morphology observation by hematoxylin-eosin staining further confirmed the results that hemin preserved the integrity of the muscle. Conclusion: The results indicated that hemin may have economic benefit for the industry based on its advantage on water holding capacity and quality of meat.

19.
Front Pediatr ; 8: 522, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33014927

RESUMO

Background: The mortality prediction scores were widely used in pediatric intensive care units. However, their performances were unclear in Chinese patients and there were also no reports based on large sample sizes in China. This study aims to evaluate the performances of three existing severity assessment scores in predicting PICU mortality and to identify important determinants. Methods: This prospective observational cohort study was carried out in eight multidisciplinary, tertiary-care PICUs of teaching hospitals in China. All eligible patients admitted to the PICUs between Aug 1, 2016, and Jul 31, 2017, were consecutively enrolled, among whom 3,957 were included for analysis. We calculated PCIS, PRISM IV, and PELOD-2 scores based on patient data collected in the first 24 h after PICU admission. The in-hospital mortality was defined as all-cause death within 3 months after admission. The discrimination of mortality was assessed using the area under the receiver-operating characteristics curve (AUC) and calibrated using the Hosmer-Lemeshow goodness-of-fit test. Results: A total of 4,770 eligible patients were recruited (median age 18.2 months, overall mortality rate 4.7%, median length of PICU stay 6 days), and 3,957 participants were included in the analysis. The AUC (95% confidence intervals, CI) were 0.74 (0.71-0.78), 0.76 (0.73-0.80), and 0.80 (0.77-0.83) for PCIS, PRISM IV, and PELOD-2, respectively. The Hosmer-Lemeshow test gave a chi-square of 3.16 for PCIS, 2.16 for PRISM IV and 4.81 for PELOD-2 (p ≥ 0.19). Cox regression identified five predictors from the items of scores better associated with higher death risk, with a C-index of 0.83 (95%CI 0.79-0.86), including higher platelet (HR = 1.85, 95% CI 1.59-2.16), invasive ventilation (HR = 1.40, 1.26-1.55), pupillary light reflex (HR = 1.31, 95% CI 1.22-1.42) scores, lower pH (HR 0.89, 0.84-0.94), and extreme PaO2 (HR 2.60, 95% CI 1.61-4.19 for the 1st quantile vs. 4th quantile) scores. Conclusions: Performances of the three scores in predicting PICU mortality are comparable, and five predictors were identified with better prediction to PICU mortality in Chinese patients.

20.
BMC Pregnancy Childbirth ; 20(1): 475, 2020 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-32819312

RESUMO

BACKGROUND: Birth defects are the main cause of fetal death, infant mortality and morbidity worldwide. However, the etiology of birth defects remains largely unknown. Maternal folate status during periconception plays an important role in organogenesis and folic acid supplement reduces the risk of neural tube defects, congenital heart diseases, and several other birth defects. This trial seeks to evaluate the effectiveness of folate-oriented tertiary interventions during periconception on the incidence of fetus and birth defects. METHODS: This is a single-blind, two-arm cluster randomized controlled trial in Shanghai, China. Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings. Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm. The core interventions consist of assessments of folate status and metabolism, folate intake guidance, and re-evaluation of folate status to ensure red blood cell folate level above 400 ng/ml (906 nmol/L) before pregnancy. Screening and consulting of fetus and birth defects, and treatments of birth defects during pregnancy and afterward will be provided to both arms. The primary outcome is a composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28 days after birth. Secondary outcomes include maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions. This protocol adheres to the SPIRIT Checklist. DISCUSSION: To achieve the recommended folate status before or during pregnancy is still a challenge worldwide. This community-based cluster-randomized controlled intervention trial will evaluate the effectiveness of a package of interventions aiming at achieving recommended maternal folate status covering pre- and during pregnancy in reducing fetus and birth defects. Our study has the potential to improve the community-based practice of reducing modifiable risk factors of disease and improving primary prevention of the defects in China. The procedures would formulate the policy on folic acid supplementation during periconception against birth defects in primary care settings. TRIAL REGISTRATION: Clinical Trial Registry, NCT03725878 . Prospectively registered on 31 October 2018.


Assuntos
Serviços de Saúde Comunitária/métodos , Anormalidades Congênitas/prevenção & controle , Ácido Fólico/uso terapêutico , Complexo Vitamínico B/uso terapêutico , Adolescente , Adulto , China , Suplementos Nutricionais , Feminino , Humanos , Incidência , Recém-Nascido , Pessoa de Meia-Idade , Defeitos do Tubo Neural/prevenção & controle , Assistência Perinatal , Cuidado Pré-Concepcional , Gravidez , Método Simples-Cego , Natimorto , Adulto Jovem
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