Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission

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

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

Study Overview

• Status: Terminated
• Conditions: Hypoglycemia; Neonatal Hypoglycemia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To detect a 130% increase in NICU length of stay with power of 0.8, the investigators calculated a sample size of 400 subjects with 200 subjects before and after implementation. It is estimated that the data collection period is roughly over the course of one year, with the assumption that not all neonates with hypoglycemia will meet the inclusion criteria.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre implementation of hypoglycemia protocol with glucose gel; All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 who qualify for hypoglycemia protocol
Post implementation of hypoglycemia protocol with glucose gel; All neonates born at Banner University Hospital during January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean NICU length of stay rounded to the day	Mean NICU length of stay rounded to the day	30 days
Mean maximum glucose infusion rate	Mean maximum glucose infusion rate	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess for complications	- Number of neonates identified to have any type of infection	30 days
Assess for weight loss	- Maximum weight loss as percent below birth weight during NICU admission	30 days
Evaluate for persistent symptomatic or asymptomatic hypoglycemia	Number of neonates with symptomatic hypoglycemia; Number of neonates with asymptomatic hypoglycemia	30 days
Number of neonates who received formula	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days
Number of neonates with any breastfeeding during hospitalization	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days
Number of neonates with breastfeeding at time of discharge	Time to gain back to birthweight (if occurred while in-house), rounded to day of life	30 days

Collaborators and Investigators

• Sponsor: Pediatrix
• Collaborators: Banner University Medical Center
• Investigators: Principal Investigator: Gregory Martin, MD, Pediatrix

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia
• Other Study ID Numbers: 501938027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No