Donor human milk cream to treat low blood sugar in newborns
Official title: The Feasibility of Prolacta CR for Treatment of Neonatal Hypoglycemia
Run by Baylor Research Institute · NCT07217483 · Data updated 2026-11-12
This pilot will see if a pasteurized donor human milk cream given to newborns at risk for low blood sugar can raise and help sustain their blood glucose.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 24 Hours |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (McKinney, Texas) |
| Status | Recruiting |
| Started | October 14, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 16, 2025 |
| Trial ID | NCT07217483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newborns born at 35–37 weeks or term who are at risk for hypoglycemia (infants of diabetic mothers, small or large for gestational age) and who remain in couplet/rooming‑in care.
✕Probably not a fit
Infants with major congenital anomalies or those admitted directly to the NICU are not eligible and are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center pilot enrolls newborns at risk for hypoglycemia (infants of diabetic mothers, small or large for gestational age, and late preterm 35–37 weeks) who remain in couplet (rooming‑in) care. When low blood glucose is detected, investigators administer Prolact CR cream at a dose of 3 mL/kg (≈0.2 g/kg carbohydrate and 0.75 g/kg fat) and monitor serial blood glucose, feasibility metrics, and parental acceptability. Primary outcomes focus on feasibility, acceptability, and preliminary glucose rise and sustainment compared with standard care pathways. The study is conducted at Baylor Scott & White Medical Center — McKinney as a pilot feasibility effort.
Why it matters
Potential benefit: If successful, the cream could provide a human‑milk–based option that both raises and helps sustain newborn blood sugar, potentially reducing need for formula, repeat glucose dosing, or NICU transfer.
How similar studies have gone: Donor‑milk fat supplements have been used to support growth in preterm infants, but using cream specifically to treat neonatal hypoglycemia is novel and has not been reported, whereas dextrose gel is an established immediate corrective therapy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns at risk for hypoglycemia (born to mothers with diabetes, small for gestational age, large for gestational age, late preterm born 35 to 37 weeks gestational age) Exclusion Criteria: * Newborns with major congenital anomalies * Newborns directly admitted to the NICU form delivery room
Where it's running
-
Baylor Scott & White Medical Center - McKinney
McKinney, Texas, United States Recruiting
Study contacts
- Study coordinator: Karen Stanzo, PhD
- Email: Karen.Stanzo@bswhealth.org
- Phone: 469-764-6282
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pasteurised donor human milk for term babies born to mothers with diabetes
This trial will try giving pasteurised donor human milk instead of formula to term infants of mothers with diabetes during the first five days to see if it reduces neonatal unit admissions for low blood sugar.
-
Monitoring blood glucose in pregnant women receiving betamethasone for fetal lung development
This study looks at how the medication betamethasone affects blood sugar levels in pregnant women who don't have diabetes but are at risk of preterm birth.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.