Prolact CR Cream for Neonatal Hypoglycemia

Overseen By Arpitha Chiruvolu, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Congenital anomalies, NICU admission, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 to 5 days

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat low blood sugar in newborns using Prolact CR, a special cream made from human milk. The cream aims to increase and stabilize blood sugar levels more effectively than the usual sugar gel, which does not maintain steady blood sugar. Babies who may be suitable for this trial include those at risk for low blood sugar, such as those born to mothers with diabetes or those born slightly early. The trial will evaluate the cream's effectiveness, the required number of doses, and the satisfaction of parents and nurses with its use. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance newborn care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on newborns and their treatment, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that Prolact CR cream is safe for treating neonatal hypoglycemia?

Research has shown that Prolact CR, a cream made from pasteurized human donor milk, has been safely used in premature babies in the NICU to support growth without cow's milk. No specific studies have examined its use for treating low blood sugar in newborns. However, because the cream is made from human milk, infants usually tolerate it well.

In similar cases, products made from human milk have been associated with positive outcomes and fewer side effects compared to those made from cow's milk. While direct data on side effects from using Prolact CR for low blood sugar is lacking, past experiences with human milk products suggest that serious side effects are unlikely. Researchers believe that newborns will tolerate the cream well without negative effects, and caregivers will find it easy to use. This is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for neonatal hypoglycemia, which typically involve intravenous glucose or feeding protocols, Prolact CR Cream offers a new approach by being a topical cream. This method could provide a more convenient and less invasive option for managing low blood sugar in newborns. Researchers are excited about Prolact CR because it could simplify treatment administration and potentially improve comfort for both infants and their caregivers by avoiding needles or tubes.

What evidence suggests that Prolact CR cream might be an effective treatment for neonatal hypoglycemia?

Research has shown that Prolact CR, a cream made from human donor milk, successfully aids the growth of premature babies. This cream is rich in fat, which provides energy and assists the body in producing sugar. While specific data on its use for treating low blood sugar in newborns is not yet available, the fat content might help stabilize sugar levels. Previous studies found that Prolact CR improves growth in premature babies and reduces the need for intensive care. This trial will evaluate Prolact CR as a potential alternative to other treatments, such as dextrose gel, for maintaining stable blood sugar in newborns. ^{1 3 6 7 8}

Who Is on the Research Team?

Arpitha Chiruvolu, MD

Principal Investigator

Baylor Scott & White Medical Center - McKinney

Are You a Good Fit for This Trial?

This trial is for newborns at risk of low blood sugar because they were born to diabetic mothers, are smaller or larger than average for their age, or were born slightly early (35-37 weeks). The babies must be intended to be exclusively breastfed. Newborns with major birth defects or those needing immediate NICU care won't qualify.

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 from delivery room

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Newborns receive Prolact CR cream for treatment of hypoglycemia

2 to 5 days

Continuous monitoring in couplet care unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prolact CR

Trial Overview The study tests Prolact CR cream as a treatment for neonatal hypoglycemia. It's derived from human donor milk and aims to stabilize blood sugar levels in newborns without using cow milk products. Researchers will see how many doses are needed and if it prevents the need for NICU admission.

How Is the Trial Designed?

Group I: Prolact CR Experimental Treatment 1 Intervention

One arm receiving Prolact CR for hypoglycemia

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217483

Study Details | NCT07217483 | The Feasibility of Cream for ... Interventional Model Description: In this study the newborns with low blood glucose, but have no symptoms, will be managed by giving 3 ml/kg of ...

2. trialx.com trialx.com/clinical-trials/listings/325203/the-feasibility-of-cream-for-treatment-of-neonatal-hypoglycemia/

The Feasibility of Cream for Treatment of Neonatal ... Prolact CR (cream) is a fat supplement that is derived from pasteurized human donor milk. It has been utilized in babies who are born ...

3. jandonline.org jandonline.org/article/S2212-2672(22)00740-7/pdf

Prophylactic Use of Prolact CR in ... A chart review of 30 VLBW babies in 2021 showed 77% of babies utilizing Prolact CR and 30% of babies utilizing Prolact +8 human milk fortifier. Following the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11054077/

Proactive Use of a Human Milk Fat Modular in the Neonatal ... In this protocol, a human milk fat modular was used only reactively when an infant had poor weight gain, fluid restriction, or hypoglycemia.

5. prolacta.com prolacta.com/en/news/Preterm-infant-study-finds-proactive-use-of-Prolact-CR-cream-improves-growth-and-reduces-NICU-costs/

Preterm infant study finds proactive use of Prolact CR ... Preterm infant study finds proactive use of Prolact CR cream improves growth and reduces NICU costs · Improved overall z-score weight change from ...

6. prolacta.com prolacta.com/en/resources-evidence/

Resources & Evidence Preterm infants fed cow's milk-derived fortifier had adverse outcomes despite a base diet of only mother's own milk.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594592/

Hypoglycemia in Neonates, Infants, and Children - NCBI - NIH Hypoglycemia in neonates, infants and children should be considered a medical emergency that can cause seizures, permanent neurological injury, and in rare ...

8. withpower.com withpower.com/clinical-trials/for-hypoglycemia

Top Hypoglycemia Clinical Trials | Power 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 ...