Study Stopped
The standard of care had changed during our wait for the Program Letter of Agreement between Phoenix Children's Hospital and Banner to administering IV glucose in the newborn nursery so we weren't able to meet our objective.
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
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
September 11, 2019
CompletedStudy Start
First participant enrolled
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedJune 3, 2025
May 1, 2025
5 months
September 5, 2019
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Assess for complications
30 days
Assess for weight loss
30 days
Evaluate for persistent symptomatic or asymptomatic hypoglycemia
30 days
Number of neonates who received formula
30 days
Number of neonates with any breastfeeding during hospitalization
30 days
- +1 more secondary outcomes
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Neonates \<34 weeks gestational age or with birth weight less than 2000 grams.
- Infants with serious congenital malformation
- Infants with a terminal disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pediatrixlead
- Banner University Medical Centercollaborator
Study Sites (1)
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Martin, MD
Pediatrix
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
September 11, 2019
Study Start
May 4, 2020
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
June 3, 2025
Record last verified: 2025-05