HypoglycemiaNCT04085978
Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission
An observational study of Hypoglycemia and Neonatal Hypoglycemia, run by Pediatrix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Hypoglycemia, Neonatal Hypoglycemia
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2020to 12 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Neonates <34 weeks gestational age or with birth weight less than 2000 grams.
- Infants with serious congenital malformation
- Infants with a terminal disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoglycemia, Neonatal Hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mean NICU length of stay rounded to the day
Mean NICU length of stay rounded to the day
Measured: 30 days
Mean maximum glucose infusion rate
Mean maximum glucose infusion rate
Measured: 30 days
Secondary outcomes (6)
Assess for complications
- Number of neonates identified to have any type of infection
Measured: 30 days
Assess for weight loss
- Maximum weight loss as percent below birth weight during NICU admission
Measured: 30 days
Evaluate for persistent symptomatic or asymptomatic hypoglycemia
- Number of neonates with symptomatic hypoglycemia
- Number of neonates with asymptomatic hypoglycemia
Measured: 30 days
Number of neonates who received formula
Time to gain back to birthweight (if occurred while in-house), rounded to day of life
Measured: 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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start4 May 2020
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Sponsor
- Investigators
- Gregory Martin, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085978
- Sponsor's protocol ID
- 501938027
- Status last verified
- May 2025
- First submitted
- 5 Sep 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of the Effects of a Hypoglycemia Protocol With Glucose Gel on NICU Admission
- ClinicalTrials.gov ID
- NCT04085978
- Acronym / sponsor ID
- 501938027
- Conditions
- Hypoglycemia, Neonatal Hypoglycemia
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 400 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 4 May 2020 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Neonates <34 weeks gestational age or with birth weight less than 2000 grams.
- Infants with serious congenital malformation
- Infants with a terminal disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean NICU length of stay rounded to the day
Time frame: 30 days
Mean NICU length of stay rounded to the day
Mean maximum glucose infusion rate
Time frame: 30 days
Mean maximum glucose infusion rate
6 secondary outcomes
Assess for complications
Time frame: 30 days
Assess for weight loss
Time frame: 30 days
Evaluate for persistent symptomatic or asymptomatic hypoglycemia
Time frame: 30 days
Number of neonates who received formula
Time frame: 30 days
Number of neonates with any breastfeeding during hospitalization
Time frame: 30 days
Number of neonates with breastfeeding at time of discharge
Time frame: 30 days
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Martin, MD principal investigator
Pediatrix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia and Neonatal Hypoglycemia, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean NICU length of stay rounded to the day (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.