Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: a Quasi-experimental Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Prophylactic administration of dextrose gel
研究概览
简要总结
This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.
详细描述
OBJECTIVE
To test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (BG) concentration after the first feeding and subsequently decrease NICU admissions for treatment of asymptomatic transient neonatal hypoglycemia (TNH) vs those given feedings alone.
STUDY DESIGN: This quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight <2500 or >4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (Insta-Glucose®); other at-risk newborns served as controls. After the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and BG was checked 30 min later. Initial BG concentrations and rate of NICU admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the Wilcoxon rank-sum test and Fisher's exact test, where appropriate. A multivariable linear regression compared first BG between groups after adjusting for at-risk categories and age at first BG concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age above 35 weeks
- •Infants less than 1 hour of age
- •Infants with informed parental consent
- •Infants who are born at the Harris Health Ben Taub Hospital in Houston, TX
排除标准
- •Infants with known metabolic, genetic, or congenital anomalies
- •Infants not expected to survive the neonatal period
- •Infants determined later to have a metabolic, genetic, or congenital anomaly that was not immediately obvious in the newborn period
- •Hypoglycemic infants with symptoms
- •Infants transferred to the Level 3 NICU for other reasons
结局指标
主要结局
Prophylactic administration of dextrose gel
时间窗: 2 hours
Give infants who meet criteria for high-risk and whose parents have consented one dose of prophylactic 40% dextrose gel (0.5ml/kg) after first feed. Assess glucose level after 1 feed and 1 application of dextrose gel, and admission to the NICU, compared to controls with similar risk factors who are not treated prophylactically.
Treatment failure of at-risk infants
时间窗: 4 days
Infants at-risk (IDM, late preterm, SGA, LGA, estimated fetal weight below 2.5kg or above 4kg, IUGR, or poor feeding) will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization.
次要结局
未报告次要终点
研究者
Mohan Pammi
Professor
Baylor College of Medicine