Neonatal HypoglycemiaNCT07217483
The Feasibility of Cream for Treatment of Neonatal Hypoglycemia
A study testing Prolact CR for hypoglycemia in people with Neonatal Hypoglycemia, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Prolact CR for hypoglycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Newborns with major congenital anomalies
- Newborns directly admitted to the NICU form delivery room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arpitha Chiruvolu, MD contact
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White Medical Center - McKinney
McKinney, Texas, 75071
Karen Stanzo, PhD, 469-764-6282, Karen.Stanzo@bswhealth.org
Karen Stanzo, PhD
About this study
Official title: The Feasibility of Prolacta CR 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 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.
Read more
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
- What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose?
- How many median doses of cream are needed?
- What percentage of infants will be discharge exclusively feeding human milk from couplet care unit?
- What percentage of the surveys will show parent/nursing satisfaction with the product?
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Prolact CR for hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolact CR for hypoglycemiaDietary supplement
Utilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia
| Study group | Role | What they receive |
|---|---|---|
| Prolact CR | Other | One arm receiving Prolact CR for hypoglycemia Receives: Dietary Supplement: Prolact CR for hypoglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NICU admission
Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia
Measured: Birth to hospital discharge at 2 to 5 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start14 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study the newborns with low blood glucose, but have no symptoms, will be managed by giving 3 ml/kg of Prolact CR (cream) instead of 0.5 ml/kg of 40% oral dextrose gel. Blood glucose will be monitored one hour after the cream is given. If needed, according to the protocol baby will receive up to three doses of cream. If baby has symptoms with low blood glucose, will receive intravenous dextrose.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arpitha Chiruvolu, MD, Study chair, Baylor Scott & White Medical Center - McKinney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217483
- Sponsor's protocol ID
- 023-279
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Prolacta CR for Treatment of Neonatal Hypoglycemia
- ClinicalTrials.gov ID
- NCT07217483
- Acronym / sponsor ID
- 023-279
- Conditions
- Neonatal Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose?
- How many median doses of cream are needed?
- What percentage of infants will be discharge exclusively feeding human milk from couplet care unit?
- What percentage of the surveys will show parent/nursing satisfaction with the product?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study the newborns with low blood glucose, but have no symptoms, will be managed by giving 3 ml/kg of Prolact CR (cream) instead of 0.5 ml/kg of 40% oral dextrose gel. Blood glucose will be monitored one hour after the cream is given. If needed, according to the protocol baby will receive up to three doses of cream. If baby has symptoms with low blood glucose, will receive intravenous dextrose.
| Arm | Type | Receives |
|---|---|---|
| Prolact CR | Other | Dietary Supplement: Prolact CR for hypoglycemiaOne arm receiving Prolact CR for hypoglycemia |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Newborns with major congenital anomalies
- Newborns directly admitted to the NICU form delivery room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolact CR for hypoglycemiaUtilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia | Dietary supplement | Prolact CR |
Primary outcome
NICU admission
Time frame: Birth to hospital discharge at 2 to 5 days of life
Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arpitha Chiruvolu, MD contact
Arpitha Chiruvolu, MD study chair
Baylor Scott & White Medical Center - McKinney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolact CR for hypoglycemia in people with Neonatal Hypoglycemia, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Stanzo, PhD (469-764-6282, Karen.Stanzo@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NICU admission (time frame: Birth to hospital discharge at 2 to 5 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.