Children with Hypoglycemia and their Later Development (the CHYLD Study)

患有低血糖的儿童及其后期发育（CHYLD 研究）

• 批准号: 8704972
• 负责人: Jane Harding
• 金额: $ 39.56万
• 依托单位: UNIVERSITY OF AUCKLAND
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-15 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8704972
• 关键词: Age-Years; Birth; Blood Glucose; Brain Injuries; Caring; Child; Childhood; Clinical; Clinical Management; Cognitive; Consent; Data; Data Analyses; Development; Diagnosis; Environment; Event; Family; Family health status; Frequencies; Glucose; Growth; Guidelines; Hour; Hypoglycemia; Intellectual functioning disability; Intervention; Language Development; Measures; Memory; Metabolic Diseases; Modeling; Monitor; Neonatal; Neonatal Hypoglycemia; Nervous System Physiology; Newborn Infant; Outcome; Parents; Performance; Perinatal; Premature Infant; Recording of previous events; Recruitment Activity; Research; Risk; Risk Factors; Schools; Severities; Testing; Time; Vision; clinical practice; cohort; cost; design; early childhood; evidence base; executive function; experience; follow-up; glucose monitor; interstitial; postnatal; prevent; randomized trial; standard care; standardize measure; sugar

DESCRIPTION (provided by applicant): Hypoglycemia is the most common metabolic disorder of the newborn, and the only known common preventable cause of brain damage in newborn babies. However, the best approach to diagnosis and management remains unclear. One major challenge is that the blood glucose concentration at which brain damage is incurred may differ in different babies, and it is not known how low, how often, or for how long low blood glucose concentrations must occur before brain damage occurs. There have been calls, including from the NICHD1, for large follow-up studies of children in whom glucose concentrations were measured in the newborn period and encompassed a range wide enough to determine relationships between glucose concentrations and later outcome. This proposal is to conduct just such a study. Our hypothesis is that developmental performance in early childhood is related to the severity, duration and frequency of low glucose concentrations in the first week after birth. The specific aims are to determine: 1. Whether the severity, duration and frequency of low glucose concentrations recorded in the first week after birth are related to clinical and developmental outcomes at 2 and 4.5 years of age. 2. Whether these relationships differ in babies with different risk factors or perinatal histories. 3. What glucose concentrations provide the best discriminatory definition for "low" in relation to these outcomes in different groups of babies, and thus may provide an evidence-based threshold for intervention. A cohort of <500 term and late preterm babies (e35 weeks) is being recruited. All are at risk of neonatal hypoglycemia, and are managed according to current clinical guidelines. All babies also have continuous interstitial glucose monitoring for at least 48 h and up to 7 d after birth. Data from these monitors are not used for clinical management, but do provide valuable information about the severity, duration and frequency of low glucose concentrations. Approximately 40% of the babies develop hypoglycemia, clinically defined as a blood glucose concentration <2.6mM, and are therefore treated. However, a further 20-30% experience episodes of interstitial glucose concentrations <2.6mM that are not detected clinically and therefore are not treated. Children of consenting parents will be assessed at 2 and 4.5 years of age. The assessments will include standardised measures of growth, neurological function, vision, cognitive and language development, memory, executive function, general health and family environment. Data analysis will include multivariate modelling to assess the relationships between neonatal glucose concentrations and developmental outcomes, with appropriate adjustment for perinatal events and potential postnatal family and environmental influences. Results will provide a much-needed evidence base to inform clinical practice in the short term, while also providing the critical evidence base upon which randomized trials of appropriate interventions can be designed.

描述（由申请人提供）：低血糖是新生儿最常见的代谢性疾病，也是新生婴儿唯一可预防的脑损伤原因。但是，诊断和管理的最佳方法尚不清楚。一个主要的挑战是，在不同的婴儿中引起脑损伤的血糖浓度可能有所不同，并且尚不知道在脑损伤发生之前必须发生低低，多久或多长时间才会发生多长时间。有呼叫，包括来自NICHD1的呼吁，对在新生儿时期测量葡萄糖浓度的大量随访研究，并涵盖了足够宽的范围，以确定葡萄糖浓度与后来的结果之间的关系。该提议就是进行这样的研究。我们的假设是，幼儿期的发育表现与出生后第一周的低血糖浓度的严重程度，持续时间和频率有关。具体目的是确定：1​​。出生后第一周记录的低葡萄糖浓度的严重程度，持续时间和频率是否与2岁和4.5岁的临床和发育结果有关。 2。这些关系在具有不同危险因素或围产期历史的婴儿中是否有所不同。 3。葡萄糖浓度为不同的婴儿组中的这些结果提供了最佳的歧视性定义，因此可以提供基于证据的干预阈值。正在招募一个<500个学期和早产婴儿（E35周）的队列。所有这些都有新生儿低血糖的风险，并且根据当前的临床准则进行管理。所有婴儿还具有连续的间质葡萄糖监测至少48小时，并在出生后长达7天。这些监视器的数据不用于临床管理，但确实提供了有关低葡萄糖浓度的严重性，持续时间和频率的宝贵信息。大约40％的婴儿患低血糖，临床定义为血糖浓度<2.6mm，因此接受治疗。然而，另外20-30％的间隙葡萄糖浓度的经历<2.6mm，未在临床上检测到，因此未被治疗。同意父母的孩子将在2岁和4.5岁时进行评估。评估将包括增长，神经功能，视力，认知和语言发展，记忆，执行功能，一般健康和家庭环境的标准化度量。数据分析将包括多元建模，以评估新生儿葡萄糖浓度和发育结果之间的关系，并对围产期事件以及潜在的产后家庭和环境影响进行适当调整。结果将提供急需的证据基础，以便在短期内为临床实践提供信息，同时还提供了可以设计适当干预措施的随机试验的关键证据基础。