Access cutting-edge neonatal hypoglycemia treatment through this clinical trial at a research site in Mckinney. Study-provided care at no cost to qualified participants.
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Access neonatal hypoglycemia specialists at no cost
This study follows strict safety protocols and ethical guidelines
All study-related neonatal hypoglycemia treatment provided free
Check if you qualify for this neonatal hypoglycemia clinical trial in Mckinney, TX
No-Cost Study Care
Local to Mckinney
Convenient for TX residents
Cutting-Edge Treatment
Access to innovative therapies
Expert Medical Care
Close monitoring by specialists
Possible Compensation*
For time and travel
*Compensation varies by study. Confirm details with coordinator.
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 1. What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose? 2. How many median doses of cream are needed? 3. What percentage of infants will be discharge exclusively feeding human milk from couplet care unit? 4. What percentage of the surveys will show parent/nursing satisfaction with the product?
Sponsor: Baylor Research Institute
Yes, this clinical trial (NCT07217483) has an active research site in Mckinney, TX that is currently enrolling participants.
Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.
Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.
Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.
If you're searching for neonatal hypoglycemia treatment options in Mckinney, TX, this clinical trial (NCT07217483) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.
Our Mckinney research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neonatal hypoglycemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.
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