Neonatal HypoglycemiaNCT04030312
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
A study testing Bottle Supplementation--Commercially-Sterilized Donor Human Milk and Bottle Supplementation--Standard Infant Formula in people with Neonatal Hypoglycemia, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk and Bottle Supplementation--Standard Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 minute to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
- Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
- Infant with blood glucose after delivery of < 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
- Deliverying mother plans to exclusively breastfeed.
Who cannot join
- Infants born and directly admitted to the newborn intensive care unit
- Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
- Infants deemed ward of state
- Mothers who do not plan to exclusively breastfeed at time of delivery
- Mothers less than 19 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.
Read the detailed description
Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
- Keywords
- neonatal, newborn, hypoglycemia, human milk, breastfed, donor milk
- Medical subject headings
- Hypoglycemia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle Supplementation--Commercially-Sterilized Donor Human MilkDietary supplement
Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
Bottle Supplementation--Standard Infant FormulaDietary supplement
Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Standard Infant Formula | Active comparator | Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of standard 20 calorie-per-ounce infant formula up to two times during the duration of the study to treat hypoglycemia. Receives: Dietary Supplement: Bottle Supplementation--Standard Infant Formula |
| Commercially-Sterilized Donor Human Milk | Experimental | Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of 20 calorie-per-ounce commercially-sterilized donor human milk up to two times during the duration of the study to treat hypoglycemia. Receives: Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula.
Measured: Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.
Secondary outcomes (2)
Exclusive Breastfeeding Duration
To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life.
Measured: Families of consented participants will be contacted when the enrolled infant is 6 months old.
Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys
To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization.
Measured: Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 May 2020
- Primary completion1 Jul 2022
- Study completion10 Apr 2023
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 University of NebraskaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa K Thoene, RD, PhD, Principal investigator, Nebraska Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030312
- Sponsor's protocol ID
- 0119-19-EP
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery
- ClinicalTrials.gov ID
- NCT04030312
- Acronym / sponsor ID
- 0119-19-EP
- Conditions
- Neonatal Hypoglycemia
- Keywords
- neonatal, newborn, hypoglycemia, human milk, breastfed, donor milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 23 Jul 2019 (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.
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.
Detailed description
Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Infant Formula | Active comparator | Dietary Supplement: Bottle Supplementation--Standard Infant FormulaInfants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of standard 20 calorie-per-ounce infant formula up to two times during the duration of the study to treat hypoglycemia. |
| Commercially-Sterilized Donor Human Milk | Experimental | Dietary Supplement: Bottle Supplementation--Commercially-Sterilized Donor Human MilkInfants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of 20 calorie-per-ounce commercially-sterilized donor human milk up to two times during the duration of the study to treat hypoglycemia. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
- Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
- Infant with blood glucose after delivery of < 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
- Deliverying mother plans to exclusively breastfeed.
Key exclusion criteria (5 listed)
- Infants born and directly admitted to the newborn intensive care unit
- Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
- Infants deemed ward of state
- Mothers who do not plan to exclusively breastfeed at time of delivery
- Mothers less than 19 years of age
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 |
|---|---|---|
| Bottle Supplementation--Commercially-Sterilized Donor Human MilkSupplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm. | Dietary supplement | Commercially-Sterilized Donor Human Milk |
| Bottle Supplementation--Standard Infant FormulaSupplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm. | Dietary supplement | Standard Infant Formula |
Primary outcome
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
Time frame: Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.
To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula.
2 secondary outcomes
Exclusive Breastfeeding Duration
Time frame: Families of consented participants will be contacted when the enrolled infant is 6 months old.
Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys
Time frame: Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Neonatal Hypoglycemia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingPhase 4
Pasteurised Donor Human Milk Supplementation for Term Babies
Neonatal Hypoglycemia, Metabolic Complication
Not yet recruiting
Umbilical Cord Glucose
Congenital Hyperinsulinism (CHI)
Active, not recruitingPhase 2
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Congenital Hyperinsulinism
Recruiting
Automated Insulin for Management of Intrapartum Glycemia
Type 1 Diabetes (T1D), Pregnancy
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. This study is not recruiting at the moment.
Melissa K Thoene, RD, PhD principal investigator
Nebraska Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottle Supplementation--Commercially-Sterilized Donor Human Milk and Bottle Supplementation--Standard Infant Formula in people with Neonatal Hypoglycemia, run by University of Nebraska 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels (time frame: Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.). 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 29 Sep 2023.