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

October 12, 2020 updated by: Pediatrix

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

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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