Donor human milk cream to treat low blood sugar in newborns
The Feasibility of Prolacta CR for Treatment of Neonatal Hypoglycemia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | N/A to 24 Hours |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (McKinney, Texas) |
| Trial ID | NCT07217483 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
McKinney, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.