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NCT07217483 · ClinicalTrials.gov registry record · NA
The Feasibility of Cream for Treatment of Neonatal Hypoglycemia
A NA study of Neonatal Hypoglycemia, sponsored by Baylor Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT07217483 is a NA study of Neonatal Hypoglycemia that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 75 participants, below the 127-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07217483, a NA study of Neonatal Hypoglycemia, is actively recruiting participants, sponsored by Baylor Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
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 m
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Prolact CR for hypoglycemia
Study Locations (1)
Texas
- Baylor Scott & White Medical Center - McKinney - McKinney
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07217483
The ClinicalTrials.gov registry entry for NCT07217483 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 127-participant average among 5 other Neonatal Hypoglycemia trials with a reported enrollment target (41% lower). The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Hypoglycemia appearing as the primary indexed condition, and to 1 intervention - of which Prolact CR for hypoglycemia is the first listed.
NCT07217483 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07217483 about?
NCT07217483 is a clinical study titled "The Feasibility of Cream for Treatment of Neonatal Hypoglycemia". 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 treat...
What is the current status of trial NCT07217483?
This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2024-10-14. Estimated completion is 2026-12-31.
What conditions does trial NCT07217483 study?
This clinical trial studies the following conditions: Neonatal Hypoglycemia.
What interventions are being tested in trial NCT07217483?
The interventions under investigation include: Prolact CR for hypoglycemia (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07217483?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217483 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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