Comparing Heel Stick Glucoses in Neonates

NCT04811612 | Unknown

• 1 other identifier: CHECK IN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Hypoglycemia

Keywords

neonatal hypoglycemia; heel stick; glucometer; warmed vs unwarmed heel stick; heat gel pack; neonatology; NICU

Outcome Measures

Primary Outcomes (1)

• Blood glucose measurement

  Difference in blood glucose measurement from warmed vs unwarmed heels

  1 day (Single time point measurement from warmed and unwarmed heel for each infant)

Study Arms (1)

Infants sampled for warmed and unwarmed heel stick glucose measurements

EXPERIMENTAL

This single study arm will be samples for blood glucose measurement using both a warmed and unwarmed heel.

Diagnostic Test: Warmed heel stick

Interventions

Warmed heel stick DIAGNOSTIC_TEST

One heel will be warmed before sampling with the other heel will not be warmed

Infants sampled for warmed and unwarmed heel stick glucose measurements

Eligibility Criteria

• Age: 0 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Diamond Children's Medical Center

Tucson, Arizona, 85719, United States

Location

Study Officials

• Kelsie E Oatmen, MD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

• Mohammad Bader, MD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsie E Oatmen, MD

CONTACT

616-581-3111; koatmen@peds.arizona.edu

Mohammad Bader, MD

CONTACT

(520) 626-6627; mbader@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 23, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

US (1)