Comparison of Warmed and Un-warmed Heel Stick Capillary Blood Glucose Samples in Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Blood glucose measurement
研究概览
简要总结
Newborn babies can develop low blood sugar (glucose) which can lead to brain injury and poor developmental outcomes. Therefore, it is important to accurately measure the blood glucose in babies. One way to measure the blood glucose is to test blood from the baby's heel with a bedside device called a point of care glucometer. This method is very common and easy; however, multiple factors can lead to an inaccurate reading. A false low reading may require additional blood testing and admission to the NICU. A false high reading could result in the medical provider missing the diagnosis of low blood glucose.
Our team wants to know if there is a difference between blood glucose measurements taken from warmed and un-warmed heels of infants. Blood flow farther away from the heart, such as in the feet and heels, may be less than the rest of the body, and might move more slowly. This could cause the glucose level to be lower in the feet and heels. Therefore, sampling blood from an un-warmed heel may result in a falsely low glucose reading.
There is some research that suggests warming the heel increases blood flow to the area; however, only one study that we know of has evaluated differences in blood glucose readings from warmed and un-warmed heels. They found significantly higher blood glucose readings from warmed heels compared to un-warmed heels in 57 babies. However, these babies were part of a larger study comparing different diets on blood glucose levels, and the heels were warmed using warm water which is no longer a current practice. The goal of this study is to compare the capillary blood glucose levels from warmed and un-warmed heels in about 100 infants who are breast and/or formula fed using the current practice of warming heels with gel heat packs.
The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel. The alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels.
详细描述
Neonatal hypoglycemia is defined by the American Academy of Pediatrics as blood glucose level less than 47 mg/dL and is one of the most common diagnoses requiring admission to the neonatal intensive care unit (NICU).1,2 The incidence of hypoglycemia in healthy newborns is approximately 5-15%, and as high as 51% in infants with risk factors.3 The cost of hospitalization of neonatal hypoglycemia is estimated to range from $2,350-$12,755.4 Hypoglycemia in the newborn has been associated with permanent brain injury including neurodevelopmental delay, learning difficulties and seizures.5 Clinically important hypoglycemia is not always associated with clinical exam findings;6 therefore, accurate measurement of blood glucose in the newborn is of great importance.
Laboratory testing of venous blood, typically plasma, is a widely accepted method of diagnosing neonatal hypoglycemia.6 However, point of care (POC) testing of capillary blood using a bedside glucometer is a common screening tool in newborn nurseries and NICUs. The POC testing method provides real time results and is an easier, less invasive sampling technique.6 Despite these conveniences, studies have found POC testing to be less accurate than venous testing.7-9 POC testing is also less accurate at lower glucose levels and readings are affected by polycythemia and hyperbilirubinemia, common findings in newborn babies.6,7,10 Inaccurate readings may result in unnecessary admissions to the NICU for additional testing and management. Therefore, efforts to optimize the accuracy POC glucose testing in screening for neonatal hypoglycemia is imperative.
One common practice thought to increase the accuracy of capillary POC glucose testing is to warm the infant's heel before blood sampling. It has been proposed that warming the heel will increase blood flow to the capillary bed and improve peripheral blood stasis that may otherwise result in a falsely low glucose reading.11,12 Current practice is to warm the heel with a gel heat pack designed and marketed specifically for the purpose of warming the infant's heel prior to blood collection. These gel heat packs are an additional cost to the hospital, and currently it is unclear if there is any significant clinical benefit to warming the infant's heel before obtaining capillary blood glucose measurements.
Various studies utilizing laser Doppler flowmetry have suggested that local warming results in increased skin blood flow and perfusion in infants.13-15 This increase in blood flow is thought to be reflected in the volume of blood collected and ease of collection. In practice, however, the effect of local warming on capillary blood collection in neonates appears to be minimal. One study found that heel warming in infants did not improve the volume of blood collected or the ease of blood collection.16 A subsequent study found that warming the heel decreased the need to squeeze the heel for blood collection, however, there was no difference in volume of blood collected or collection time.17 To the best of our knowledge, the only study that has directly compared the effect of warming the heel on capillary blood glucose in infants was conducted by Russell and McKay in 1966.18 The study compared simultaneously collected capillary blood glucose levels from a warmed and un-warmed heel in 57 infants. Overall, glucose levels from the warmed and un-warmed heels were highly significantly correlated. However, the mean glucose concentration from blood in warmed heels was 2.8 mg/dL higher than that from un-warmed heels. Additionally, of the 57 infants, 13 had a statistically significant higher glucose level measured in their warmed heel compared to their un-warmed heel.
The Russell and McKay study suggested that the infant's heel must always be warmed before collecting capillary blood for glucose measurement. However, the study included only 57 infants, a subset of which were also assigned to a low calorie, high calorie, or hydrocortisone administration groups to determine the outcomes of these interventions on blood glucose levels. Additionally, the infant's heels were warmed by soaking in warm water. This is no longer the current practice as most institutions use gel heat packs designed specifically for warming the heels of infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 48 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria include newborns born at 35 weeks gestation or greater and are admitted to the NICU or newborn nursery at Banner Tucson. Babies will be age 0-48 hours old and require a point of care blood glucose check for any reason.
排除标准
- •Exclusion criteria includes babies who are diagnosed with sepsis or who there is concern for sepsis or other severe illness.
结局指标
主要结局
Blood glucose measurement
时间窗: 1 day (Single time point measurement from warmed and unwarmed heel for each infant)
Difference in blood glucose measurement from warmed vs unwarmed heels
次要结局
未报告次要终点
研究者
Kelsie Oatmen
Resident
University of Arizona
