Impact of Continuous Glucose Monitoring on Cerebral Oxygenation in Preterm Infants (the Babyglucolight Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- CGMS and brain hemodynamic (posterior areas)
研究概览
简要总结
Neonatal hypoglicaemia is associated with impaired neurodevelopment outcomes in preterm infants. Thus, hypoglicemic events should be diagnosed and treated promptly. Unfortunately, hypo- and hyperglicaemia management is still controversial.
The investigators aim to assess if a continuous glucose monitor (CGM) impacts on both short-term and long-term neurodevelopment. Primary outcome is the effect of CGM coupled with a control algorithm for glucose infusion on the number of hemodynamic significant events (defined as hypoglycemic events associated with DOT-detectable reduction of brain oxygenation).
It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, they will be randomized in two study arms, both of them will wear Medtronic CGM during the first 5 days of life: 1) Blinded group (B): the device monitor will be switched off, glucose infusion rate will be modified according to the daily capillary glucose tests. 2) Unblinded group (UB): the device monitor will be visibile, alarms for hypos/hyper will be active and glucose infusion rate will be modulated according to CGM and PID control algorithm.
Enrolled newborns will also be monitored with near-infrared diffuse optical tomography (DOT) during the first 5 days from enrollment.
Follow-up will be performed at 12, 18, 24 months and 5 years by neurodevleopmental scale (Bailey III until 24 months; Wechsler Preschool and Primary Scale of Intelligence (WPPSI) at 5 years).
The estimated numerosity is 60 patients (30 for each arm).
详细描述
Background - Hypoglycaemia is a very common event during the first week of life, it affects up to 15% of term newborns and it is more frequent in preterm and IUGR (Intrauterine Growth Restriction with birth weight <10th percentile) infants.
Repeated and prolonged hypoglicemic events are associated with impaired neurodevelopment outcomes in preterm infants and should be diagnosed and treated promptly (Tam EWY et al, J Pediatrics 2012; Duvanel et al, J Ped 1999; Lucas et al BMJ; 1988; Filam PM et al, J Pediatr 2006).
Unfortunately, the management of hypo / hyperglycaemias in these groups is still controversial due to the lack of Continuous Glucose Monitoring System's (CGMS) efficacy assessments in the Neonatal Care Intensive Units.
Nevertheless, recent studies indicate that CGMS is reliable and can identify a significant number of hypoglycaemias (<40mg / dl, duration> 30 minutes) which could not be recognized through traditional glycemic monitoring (Pertierra Cortada et al, J Ped 2014; Beardsall et al, Arch Dis Child Fetal&Neonatal Ed 2013).
The reliability of data provided by CGMS were highlighted by Beardsall and colleagues (Beardsall et al, Arch Dis Child Fetal & Neonatal Ed 2013) on a population of newborns with an average birth weight of 1007 gr (SD 0.27) and a gestational age of 28.36 SG (SD 2.26), the study showed a high correlation (0.94) between capillary monitoring data (traditional) and data provided by the CGMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Hours 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<= 32 weeks gestation
- •birthweight <1500 g
排除标准
- •birthweight <500g
- •congenital pathologies
- •lack of parental consent
- •perinatal maternal infections
结局指标
主要结局
CGMS and brain hemodynamic (posterior areas)
时间窗: 5 days
Number of hypoglycemic events henomdynamically significant. Hypoglycemic events are defined as any value \<72mg/dL (mild hypo) or \<47mg/dL (severe hypo). They are classified as "significant" in the presence of a reduction from baseline HbT \>=15% (posterior areas)
次要结局
- Long-term neurodevelopment 3(18 months)
- CGMS and brain hemodynamic (overall-hyperglycemia)(5 days)
- Intervention and brain hemodynamic(5 days)
- Long-term neurodevelopment(24 months)
- CGMS and brain hemodynamic (overall)(5 days)
- Long-term neurodevelopment 2(12 months)
- Long-term neurodevelopment 4(50 months)
研究者
Alfonso Galderisi
MD, PhD
University Hospital Padova