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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04085978
Enrollment
400
Registered
2019-09-11
Start date
2020-05-04
Completion date
2020-10-12
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Neonatal Hypoglycemia

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.

Interventions

None listed

Sponsors

Banner University Medical Center
CollaboratorOTHER
Pediatrix
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
34 Weeks to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean NICU length of stay rounded to the day30 daysMean NICU length of stay rounded to the day
Mean maximum glucose infusion rate30 daysMean maximum glucose infusion rate

Secondary

MeasureTime frameDescription
Evaluate for persistent symptomatic or asymptomatic hypoglycemia30 days* Number of neonates with symptomatic hypoglycemia * Number of neonates with asymptomatic hypoglycemia
Number of neonates who received formula30 daysTime to gain back to birthweight (if occurred while in-house), rounded to day of life
Assess for complications30 days\- Number of neonates identified to have any type of infection
Number of neonates with breastfeeding at time of discharge30 daysTime to gain back to birthweight (if occurred while in-house), rounded to day of life
Number of neonates with any breastfeeding during hospitalization30 daysTime to gain back to birthweight (if occurred while in-house), rounded to day of life
Assess for weight loss30 days\- Maximum weight loss as percent below birth weight during NICU admission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026