Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Detection of hypo- and hyperglycemia - CGM device
研究概览
简要总结
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants (gestational age (GA) at birth < 31 weeks)
- •admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
- •written informed consent can be secured from a parent within 96 hours of birth.
排除标准
- •Infants born at ≥31 weeks GA
- •infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development
- •children experiencing severe birth asphyxia,
- •children enrolled in another nutritional study,
- •children likely to be transferred out of the NICU
结局指标
主要结局
Detection of hypo- and hyperglycemia - CGM device
时间窗: 10 days post placement of CGM
Proportion of CGM device readings that match blood glucose readings
Detection of hypo- and hyperglycemia - 60 mg/dL
时间窗: 10 days post placement of CGM
% time below 60 mg/dL
Detection of hypo- and hyperglycemia - 180 mg/dL
时间窗: 10 days post placement of CGM
% time above 180 mg/dL
Detection of hypo- and hyperglycemia - AEs
时间窗: 10 days post placement of CGM
% of infants with adverse events secondary to CGM placement or wear
次要结局
未报告次要终点