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This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.
OBJECTIVE: To test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (BG) concentration after the first feeding and subsequently decrease NICU admissions for treatment of asymptomatic transient neonatal hypoglycemia (TNH) vs those given feedings alone.
STUDY DESIGN: This quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight <2500 or >4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (Insta-Glucose®); other at-risk newborns served as controls. After the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and BG was checked 30 min later. Initial BG concentrations and rate of NICU admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the Wilcoxon rank-sum test and Fisher's exact test, where appropriate. A multivariable linear regression compared first BG between groups after adjusting for at-risk categories and age at first BG concentration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | No Intervention | Infants at risk for transient neonatal hypoglycemia following standard-of-care. | |
| Dextrose Gel | Active Comparator | Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40% Dextrose gel | Dietary Supplement | 40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prophylactic administration of dextrose gel | Give infants who meet criteria for high-risk and whose parents have consented one dose of prophylactic 40% dextrose gel (0.5ml/kg) after first feed. Assess glucose level after 1 feed and 1 application of dextrose gel, and admission to the NICU, compared to controls with similar risk factors who are not treated prophylactically. | 2 hours |
| Treatment failure of at-risk infants | Infants at-risk (IDM, late preterm, SGA, LGA, estimated fetal weight below 2.5kg or above 4kg, IUGR, or poor feeding) will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Kaiser, MD, MA, FAAP | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Harris Health Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29605395 | Derived | Coors SM, Cousin JJ, Hagan JL, Kaiser JR. Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: A Quasi-Experimental Pilot Study. J Pediatr. 2018 Jul;198:156-161. doi: 10.1016/j.jpeds.2018.02.025. Epub 2018 Mar 28. |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D047928 | Premature Birth |
| D005320 | Fetal Macrosomia |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
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Pilot Study
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D016640 | Diabetes, Gestational |
| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |