Abstract:
Importance:Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives:To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products. Design, Setting, and Participants:A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee. Results:An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures. Conclusions and Relevance:Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.
journal_name
JAMA Pediatrjournal_title
JAMA pediatricsauthors
Jarrold K,Helfer B,Eskander M,Crawley H,Trabulsi J,Caulfield LE,Duffy G,Garcia-Larsen V,Hayward D,Hyde M,Jeffries S,Knip M,Leonardi-Bee J,Loder E,Lodge CJ,Lowe AJ,McGuire W,Osborn D,Przyrembel H,Renfrew MJ,Trumbodoi
10.1001/jamapediatrics.2020.0578subject
Has Abstractpub_date
2020-09-01 00:00:00pages
874-881issue
9eissn
2168-6203issn
2168-6211pii
2765822journal_volume
174pub_type
杂志文章相关文献
JAMA Pediatrics文献大全abstract:Importance:Childhood anxiety is common. Multiple treatment options are available, but existing guidelines provide inconsistent advice on which treatment to use. Objectives:To evaluate the comparative effectiveness and adverse events of cognitive behavioral therapy (CBT) and pharmacotherapy for childhood anxiety disord...
journal_title:JAMA pediatrics
pub_type: 杂志文章,meta分析,评审
doi:10.1001/jamapediatrics.2017.3036
更新日期:2017-11-01 00:00:00
abstract:Importance:Corporal punishment is a leading risk factor for physical abuse. Strong anecdotal evidence from physicians and other professionals working in child protection suggest that punishment-initiated physical abuse for school-aged children increases after release of report cards. However, no empirical examination o...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2018.4346
更新日期:2019-02-01 00:00:00
abstract:Importance:Sales of specialized formula for managing cow's milk allergy (CMA) have increased, triggering concern that attribution of common infant symptoms, such as crying, vomiting, and rashes, to CMA may be leading to overdiagnosis, which could undermine breastfeeding. Objective:To understand whether CMA guideline r...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.0153
更新日期:2020-06-01 00:00:00
abstract:IMPORTANCE:Early adversity is an important risk factor that relates to internalizing symptoms and altered brain structure. OBJECTIVE:To assess the direct effects of early adversity and child internalizing symptoms (ie, depression, anxiety) on cortical gray matter (GM) volume, as well as the extent to which early adver...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2015.1486
更新日期:2015-10-01 00:00:00
abstract:Importance:Cycled (intermittent) phototherapy (PT) might adequately control peak total serum bilirubin (TSB) level and avoid mortality associated with usual care (continuous PT) among extremely low-birth-weight (ELBW) infants (401-1000 g). Objective:To identify a cycled PT regimen that substantially reduces PT exposur...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.0559
更新日期:2020-07-01 00:00:00
abstract:Importance:Incorporating combination vaccines, such as the measles-mumps-rubella-varicella (MMRV) vaccine, into immunization schedules should be evaluated from a benefit-risk perspective. Use of MMRV vaccine poses challenges due to a recognized increased risk of febrile seizures (FSs) when used as the first dose in the...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2017.1965
更新日期:2017-10-01 00:00:00
abstract:Importance:Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known. Objective:To compare the cost-effectiveness of treatment with antenatal corticosteroids wi...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamapediatrics.2019.0032
更新日期:2019-05-01 00:00:00
abstract:Importance:Approximately 90% of adult smokers first tried a cigarette by 18 years of age, and even infrequent smoking in adolescence is associated with established adult smoking. Noncigarette tobacco use is increasing and could stimulate subsequent conventional cigarette smoking in youths. Objective:To estimate the lo...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2017.4173
更新日期:2018-02-01 00:00:00
abstract:Importance:Supplemental oxygen is commonly administered to pregnant women at the time of delivery to prevent fetal hypoxia and acidemia. There is mixed evidence on the utility of this practice. Objective:To compare the association of peripartum maternal oxygen administration with room air on umbilical artery (UA) gas ...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.5351
更新日期:2021-01-04 00:00:00
abstract:Importance:Fexofenadine hydrochloride is a frequently used drug for treatment of allergic conditions during pregnancy, but the fetal safety of fexofenadine use has not been well studied. Objective:To investigate the risk of adverse fetal outcomes associated with fexofenadine use during pregnancy. Design, Setting, and...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.1316
更新日期:2020-08-01 00:00:00
abstract:Importance:Traumatic brain injury (TBI) in children results in a high number of emergency department visits and risk for long-term adverse effects. Objectives:To estimate lifetime prevalence of TBI in a nationally representative sample of US children and describe the association between TBI and other childhood health ...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2018.2740
更新日期:2018-11-01 00:00:00
abstract:IMPORTANCE:There has been a significant expansion in the number of low-level and midlevel neonatal intensive care units (NICUs) in recent decades. Infants with necrotizing enterocolitis represent a high-risk subgroup of the very low-birth-weight (VLBW) (<1500 g) population that would benefit from focused regionalizatio...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2014.2085
更新日期:2015-01-01 00:00:00
abstract:IMPORTANCE:Obesity affects health in children and adolescents. Television viewing is an established risk factor for obesity in youth. No prospective study has assessed whether a bedroom television confers an additional risk for obesity in youth. OBJECTIVE:To assess the prospective association between the presence of a...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2013.3921
更新日期:2014-05-01 00:00:00
abstract:Importance:Adverse childhood experiences (ACEs) are associated with long-term poor mental health. Less is known about factors that improve long-term mental health among those with ACEs. Objective:To evaluate, among those exposed to ACEs, whether team sports participation during adolescence is associated with better me...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2019.1212
更新日期:2019-07-01 00:00:00
abstract:IMPORTANCE:Community-based efforts to prevent adolescent problem behaviors are essential to promote public health and achieve collective impact community wide. OBJECTIVE To test whether the Communities That Care (CTC) prevention system reduced levels of risk and adolescent problem behaviors community wide 8 years after...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamapediatrics.2013.4009
更新日期:2014-02-01 00:00:00
abstract:Importance:Pediatric patients often encounter anxiety and distress in hospital settings, and virtual reality education, providing a vivid, immersive, and realistic experience, has been introduced to mitigate these anxiety responses. Objective:To evaluate whether virtual reality education for pediatric patients before ...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2019.3000
更新日期:2019-09-09 00:00:00
abstract:IMPORTANCE:Most patients with asthma take fewer than half of prescribed doses of controller medication. Interventions to improve adherence have typically been costly, impractical, and at best only minimally successful. OBJECTIVE:To test a speech recognition (SR) intervention to improve adherence to pediatric asthma co...
journal_title:JAMA pediatrics
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamapediatrics.2014.3280
更新日期:2015-04-01 00:00:00
abstract:IMPORTANCE:Rape on college campuses has been addressed recently by a presidential proclamation, federal legislation, advocacy groups, and popular media. Many initiatives assume that most college men who perpetrate rape are serial rapists. The scientific foundation for this perspective is surprisingly limited. OBJECTIV...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2015.0707
更新日期:2015-12-01 00:00:00
abstract:Importance:Rap artists are among the most recognizable celebrities in the US, serving as role models to an increasingly diverse audience of listeners. Through their lyrics, these artists have the potential to shape mental health discourse and reduce stigma. Objective:To investigate the prevalence and nature of mental ...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.5155
更新日期:2020-12-07 00:00:00
abstract:Importance:The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) uses the Sequential Organ Failure Assessment (SOFA) score to grade organ dysfunction in adult patients with suspected infection. However, the SOFA score is not adjusted for age and therefore not suitable for children. Objec...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2017.2352
更新日期:2017-10-02 00:00:00
abstract:Importance:Sudden infant death syndrome remains the leading cause of death in infants aged 1 month to 1 year in the United States. Observations:While its exact cause is unknown, sudden infant death syndrome is believed to be multifactorial, ie, occurs in infants with underlying biological vulnerability who experience ...
journal_title:JAMA pediatrics
pub_type: 杂志文章,评审
doi:10.1001/jamapediatrics.2016.3345
更新日期:2017-02-01 00:00:00
abstract:IMPORTANCE:Although data obtained from regional trauma systems demonstrate improved outcomes for children treated at pediatric trauma centers (PTCs) compared with those treated at adult trauma centers (ATCs), differences in mortality have not been consistently observed for adolescents. Because trauma is the leading cau...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1001/jamapediatrics.2016.0805
更新日期:2016-08-01 00:00:00
abstract:Importance:Acute kidney injury (AKI) occurs commonly in preterm neonates and is associated with increased morbidity and mortality. Objectives:To examine the association between caffeine citrate administration and AKI in preterm neonates in the first 7 days after birth and to test the hypothesis that caffeine administr...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1001/jamapediatrics.2018.0322
更新日期:2018-06-04 00:00:00
abstract:Importance:The prevalence of autism spectrum disorder (ASD) has been increasing rapidly, with current estimates of 1 in 68 children affected. Simultaneously, use of prenatal ultrasonography has increased substantially, with limited investigation into its safety and effects on brain development. Animal studies have demo...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2017.5634
更新日期:2018-04-01 00:00:00
abstract:IMPORTANCE:Given the importance of developing healthy eating patterns during early childhood, policies to improve the elementary school food and beverage environments are critical. OBJECTIVE:To examine the association between district and state policy and/or law requirements regarding competitive food and beverages an...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2013.32
更新日期:2013-08-01 00:00:00
abstract:IMPORTANCE:Exchange transfusion is recommended for newborns with total serum bilirubin (TSB) levels thought to place them at risk for cerebral palsy (CP). However, the excess risk for CP among these infants is unknown. OBJECTIVE:To quantify the risks for CP and CP consistent with kernicterus that are associated with h...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2014.3036
更新日期:2015-03-01 00:00:00
abstract:IMPORTANCE:Although cancer remains the most common cause of disease-related death in adolescents and young adults (AYAs) in high-income countries, their overall survival rates continue to increase and now exceed 80% at 5 years in several high-income countries. This has been accomplished through progressive improvements...
journal_title:JAMA pediatrics
pub_type: 杂志文章,评审
doi:10.1001/jamapediatrics.2015.4689
更新日期:2016-05-01 00:00:00
abstract:Importance:Genome-wide association studies have identified genetic loci influencing obesity risk in children. However, the importance of these loci in the associations with weight reduction through lifestyle interventions has not been investigated in large intervention trials. Objective:To evaluate the associations be...
journal_title:JAMA pediatrics
pub_type: 杂志文章
doi:10.1001/jamapediatrics.2020.5142
更新日期:2021-01-01 00:00:00
abstract:IMPORTANCE:Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection (STI)/human immunodeficiency virus (HIV) risk behaviors; however, few have demonstrated long-term efficacy. OBJECTIVE:To evaluate the efficacy of a telephone counseling prevention maintenance int...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamapediatrics.2014.1436
更新日期:2014-10-01 00:00:00
abstract:Importance:Retention in addiction treatment is associated with reduced mortality for individuals with opioid use disorder (OUD). Although clinical trials support use of OUD medications among youths (adolescents and young adults), data on timely receipt of buprenorphine hydrochloride, naltrexone hydrochloride, and metha...
journal_title:JAMA pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1001/jamapediatrics.2018.2143
更新日期:2018-11-01 00:00:00