An observational study in Hypoglycemia and Neonatal Hypoglycemia, sponsored by Pediatrix. Terminated at 1 site in United States. Open to participants aged 34 Weeks and older. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Pediatrix · Observational
Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.
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.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 400 is above the median of 86 across 131 observational studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 who qualify for hypoglycemia protocol
All neonates born at Banner University Hospital during January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol
Mean NICU length of stay rounded to the day
Mean NICU length of stay rounded to the day
Time frame: 30 days
Mean maximum glucose infusion rate
Mean maximum glucose infusion rate
Time frame: 30 days
Assess for complications
- Number of neonates identified to have any type of infection
Time frame: 30 days
Assess for weight loss
- Maximum weight loss as percent below birth weight during NICU admission
Time frame: 30 days
Evaluate for persistent symptomatic or asymptomatic hypoglycemia
* Number of neonates with symptomatic hypoglycemia * Number of neonates with asymptomatic hypoglycemia
Time frame: 30 days
Number of neonates who received formula
Time to gain back to birthweight (if occurred while in-house), rounded to day of life
Time frame: 30 days
Number of neonates with any breastfeeding during hospitalization
Time to gain back to birthweight (if occurred while in-house), rounded to day of life
Time frame: 30 days
Number of neonates with breastfeeding at time of discharge
Time to gain back to birthweight (if occurred while in-house), rounded to day of life
Time frame: 30 days
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pediatrix