- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085978
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
Conditions
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
|
|
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Hypoglycemia
-
University of California, San DiegoDexCom, Inc.Recruiting
-
Vogenx, Inc.Active, not recruitingPostbariatric HypoglycemiaUnited States
-
Joslin Diabetes CenterDexCom, Inc.CompletedHypoglycemia | Hypoglycemia, ReactiveUnited States
-
Nutricia ResearchCompletedPostprandial HypoglycemiaNetherlands
-
Tel-Aviv Sourasky Medical CenterUnknown
-
University of UlmRecruitingHypoglycemia, ReactiveGermany
-
University of ArizonaNot yet recruiting
-
Milton S. Hershey Medical CenterDexCom, Inc.; Children's Miracle NetworkRecruiting
-
Zealand University HospitalUnknownHypoglycemia, ReactiveDenmark
-
MBX BiosciencesProSciento, Inc.RecruitingPostbariatric HypoglycemiaUnited States