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Prolact CR (cream) is a fat supplement that is derived from pasteurized human donor milk. It has been utilized in babies who are born premature in the neonatal intensive care unit (NICU) setting to improve growth while avoiding cow milk exposure. There is no literature on the use of cream as a treatment for low blood glucose levels in newborns who are at risk. It is known that fat in human colostrum plays a vital role in providing energy, substrate, and stimulates gluconeogenesis. Gluconeogenesis is the process that helps in the sustainment of blood glucose. Dextrose gel that is used to treat low blood glucose levels helps in raising the blood glucose, but does not help in sustainment.
The objective of this pilot study is to evaluate the utility, feasibility, and acceptability of administering cream for the treatment of newborn low blood glucose levels in a couplet care unit. Investigators hypothesized that 3 ml/kg of cream (0.2 g/kg of carbohydrate and 0.75 g/kg of fat), if given in the place of 0.5 ml/kg (0.2 g/kg of carbohydrate) would increase and stabilize the blood glucose levels. Investigators also speculated that newborns would tolerate the cream with no adverse effects, and caregivers (nurses and parents) would find its use feasible and acceptable.
Parents of newborns with risk factors for hypoglycemia [born to mothers with diabetes, small for gestational age, large for gestational age, or late prematurity (35 to 37 weeks' gestation at birth) who intended to breastfeed exclusively will be approached to consent for the study either before or after delivery of the infant. Newborns with major congenital anomalies or those admitted immediately to the NICU after birth will be excluded.
The main questions hoping to answer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolact CR | Other | One arm receiving Prolact CR for hypoglycemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolact CR for hypoglycemia | Dietary Supplement | Utilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| NICU admission | Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia | Birth to hospital discharge at 2 to 5 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Stanzo, PhD | Contact | 469-764-6282 | Karen.Stanzo@bswhealth.org | |
| Arpitha Chiruvolu, MD | Contact | Arpitha.Chiruvolu@bswhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Arpitha Chiruvolu, MD | Baylor Scott & White Medical Center - McKinney | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Medical Center - McKinney | Recruiting | McKinney | Texas | 75071 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2025 | Oct 9, 2025 | ICF_000.pdf |
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In this study the newborns with low blood glucose, but have no symptoms, will be managed by giving 3 ml/kg of Prolact CR (cream) instead of 0.5 ml/kg of 40% oral dextrose gel. Blood glucose will be monitored one hour after the cream is given. If needed, according to the protocol baby will receive up to three doses of cream. If baby has symptoms with low blood glucose, will receive intravenous dextrose.
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