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New treatment option for Neonatal Hypoglycemia
Official title Continuous Glucose Monitoring in At-Risk Newborns
ClinicalTrials.gov ID: NCT04386005
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 2
You may be able to join if
- At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
- Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
- Large for gestational age (LGA, \>90th percentile [sex-specific])
- Small for gestational age (SGA, \<10th percentile [sex-specific])
- Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
You likely can't join if
- Birth weight \<2kg
- hypoxic-ischemic encephalopathy
- a contraindication to oral feeding
- abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
- chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
- infants who are not expected to survive or who are in extremis
See the full eligibility criteria
- At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
- Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
- Large for gestational age (LGA, \>90th percentile [sex-specific])
- Small for gestational age (SGA, \<10th percentile [sex-specific])
- Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
- Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic...
- Birth weight \<2kg
- hypoxic-ischemic encephalopathy
- a contraindication to oral feeding
- abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
- chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
- infants who are not expected to survive or who are in extremis
- additional risk of immunocompromise, including:
- Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
- Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
- Systemic sepsis, viral syndromes
- Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases
- Abdominal wall defects
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 minute to 2 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.