跳至主要内容
临床试验/NCT04085978
NCT04085978终止不适用

A Retrospective Analysis of the Effects of a Hypoglycemia Protocol With Glucose Gel on NICU Admission

Pediatrix1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Pediatrix
入组人数
400
试验地点
1
主要终点
Mean maximum glucose infusion rate

研究概览

简要总结

Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.

详细描述

This project will evaluate various aspects of infants with hypoglycemia admitted to the Neonatal Intensive Care Unit (NICU) pre- and post- implementation of a hospital-wide hypoglycemia protocol with oral glucose gel. Subjects will be matched by gestational age (GA), birth weight rounded to the nearest half kilogram, ethnicity, gender, maternal age, maternal diabetes status, maternal parity, maternal ethnicity, and mode of delivery. Retrospective data will be reviewed including neonatal and maternal demographics and NICU medical course data. The results of this study can inform intended and unintended consequences of the instituted protocol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
34 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

排除标准

  • Neonates <34 weeks gestational age or with birth weight less than 2000 grams.
  • Infants with serious congenital malformation
  • Infants with a terminal disorder.

结局指标

主要结局

Mean maximum glucose infusion rate

时间窗: 30 days

Mean maximum glucose infusion rate

Mean NICU length of stay rounded to the day

时间窗: 30 days

Mean NICU length of stay rounded to the day

次要结局

  • Assess for weight loss(30 days)
  • Assess for complications(30 days)
  • Evaluate for persistent symptomatic or asymptomatic hypoglycemia(30 days)
  • Number of neonates who received formula(30 days)
  • Number of neonates with any breastfeeding during hospitalization(30 days)
  • Number of neonates with breastfeeding at time of discharge(30 days)

研究者

发起方
Pediatrix
申办方类型
Other
责任方
Sponsor

研究点 (1)

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