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NCT04386005 · ClinicalTrials.gov registry record · NA
Continuous Glucose Monitoring in At-Risk Newborns
A NA study of Neonatal Hypoglycemia, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04386005 is a NA study of Neonatal Hypoglycemia that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 100 participants, below the 122-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04386005, a NA study of Neonatal Hypoglycemia, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers \[IDM\], large \[LGA\] and small \[SGA\] for gestational age infants, and late preterm \[LPT\] infants) undergo a hypoglycemia screening protocol that involves numerous intermittent needle sticks to test glucose levels on bedside glucometers; however, continuous glucose monitoring (CGM, currently not approved for clinical use in babies), via a small sensor placed in the thigh (only 1 needle stick), would likely decrease pain while providing continuous glucose levels. This study will evaluate the feasibility, safety, and precision of CGM in at-risk newborns, and determine if this method would decrease the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling. As part of regular medical care, participants will undergo intermittent blood glucose screening with heel sticks as per the current hospital standard of care protocol. Regular medical care involves checking the participant's blood glucose via heel stick every few hours using a bedside glucometer, with another heel stick to confirm low values in the laboratory. If the participant has low values, he/she may be treated with oral glucose gel, feedings of breast milk or formula, or intravenous (IV) fluids in the Neonatal Intensive Care Unit (NICU). This research study involves placing a CGM device in addition to undergoing the current blood glucose screening protocol and treatment. As soon as possible after birth, a continuous glucose monitoring device (Dexcom G7) will be placed on the participant's thigh by a research team member, and will blindly continuously record glucose levels that will be analyzed after discharge. Everyone who agrees to participate in this study will have placement of this experimental device. The investigational device will stay in place for the same amo
Conditions Studied
Interventions
- DEVICE Continuous Glucose Monitoring Device
Study Locations (1)
Pennsylvania
- Penn State Health Milton S Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04386005
The ClinicalTrials.gov registry entry for NCT04386005 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 122-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (18% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Hypoglycemia appearing as the primary indexed condition, and to 1 intervention - of which Continuous Glucose Monitoring Device is the first listed.
NCT04386005 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04386005 about?
NCT04386005 is a clinical study titled "Continuous Glucose Monitoring in At-Risk Newborns". Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers \[IDM\], large \[LGA\] and small \[SGA\] for gestational age infants, and late preterm \[LPT\] i...
What is the current status of trial NCT04386005?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-08-09. Estimated completion is 2026-06.
What conditions does trial NCT04386005 study?
This clinical trial studies the following conditions: Neonatal Hypoglycemia.
What interventions are being tested in trial NCT04386005?
The interventions under investigation include: Continuous Glucose Monitoring Device (DEVICE).
Who is sponsoring clinical trial NCT04386005?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04386005 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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