Accuracy of Interstitial Continuous Glucose Sensors in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 主要终点
- Point Accuracy: System agreement analysis
研究概览
简要总结
Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.
详细描述
Glycemic control in newborns remains a major challenge for neonatal care. One third of U.S. infants are screened for neonatal hypoglycemia (NH) with repeated, painful heel sticks, most commonly based on dichotomous maternal diabetes determination or newborn size. Yet, less than 50% of these infants subsequently develop and are treated for hypoglycemia. If treatment is needed, it is based on "operational thresholds" that do not account for the actual effect of glycemia on brain metabolism, nor for its long-term consequences, and potentially expose infants to unnecessary treatment that may further amplify harm. Thus, both screening and treatment for NH lack precision and are not driven by physiology or outcome.
Improving NH risk stratification requires maternal metabolic and neonatal glycemic characterization in a cohort that includes dyads considered at-risk, with comparison to not-at-risk controls. Establishing "functional thresholds" for glycemic treatment requires evaluation of reliable bedside measurable proxies of brain metabolic "health" during the neonatal period. Further, these need to contextualised within the longitudinal trajectory of the domains known to be impacted by NH, namely executive and visual motor function. These critical domains have not been investigated together in one pre-birth, longitudinal cohort, and this knowledge gap has limited advancements in NH care.
- The primary objective of this observational study is to characterize the Abbott FreeStyle Libre 3 Pro continuous glucose monitoring system performance with respect to point of care whole blood reference in neonates.
- A secondary objective is to determine maternal and neonatal predictors of NH and child neurodevelopment.
- A secondary objective is to identify glycemic and cerebral saturation thresholds of exposure linked to adverse neurodevelopment.
Study Design
• Non-randomized, single arm, single-center, prospective, observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women aged 18 years or older
- •speaks English, Spanish, Portuguese, or Haitian Creole
- •pregnant >24 weeks gestation with singleton pregnancy
排除标准
- •known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff
- •plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island
结局指标
主要结局
Point Accuracy: System agreement analysis
时间窗: From time of birth to discharge, an average of 3 days
Number and percent of glucose monitoring (GM) sensor results within the intervals +/- 20% of glucose reference throughout the system measuring range
次要结局
- Episodes of neonatal hypoglycemia (NH) by risk factors(Between birth to 72 hours after birth)
- NNNS scores(From time of birth to 72 hours after birth, at an average of 48 hours of age)
- ASQ scores(6 months and 12 months)
研究者
Sarbattama Rimi Sen
Vice Chair Pediatric Clinical Research
Women and Infants Hospital of Rhode Island