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

Terminated

• Conditions: Hypoglycemia; Neonatal Hypoglycemia

• Registration Number: NCT04085978
• Lead Sponsor: Pediatrix

Brief Summary

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

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2020-05-04
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean maximum glucose infusion rate	30 days	Mean maximum glucose infusion rate
Mean NICU length of stay rounded to the day	30 days	Mean NICU length of stay rounded to the day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States