Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04386005
Eligibility Criteria:
Inclusion Criteria:
* At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
1. Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
2. Large for gestational age (LGA, \>90th percentile \[sex-specific\])
3. Small for gestational age (SGA, \<10th percentile \[sex-specific\])
4. 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 steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)
Exclusion Criteria:
* 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:
1. Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
2. Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
3. Systemic sepsis, viral syndromes
4. 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
5. Abdominal wall defects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
2 Weeks
Study:
NCT04386005
Study Brief:
Protocol Section:
NCT04386005