Premature BirthMAGICNCT05256927
Is Milk Associated with Glycemia in the NICU
An observational study of Premature Birth, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. Read more about this study
- Who is it for?
- Ages 0 days to 3 months
- Conditions the study is for
- Premature Birth
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to 10 Mar 2024
- Phase
- Observational
- 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 0 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants admitted to the University of Rochester Medical Center that are <30 weeks gestation and/or weigh <1250g at birth.
Who may be able to join
- Infants eligible to receive human milk (HM)-derived fortifiers. To qualify for these fortifiers, infants must be born <30 weeks gestation and/or weigh <1250g at birth. Enteral or oral feeding modes both qualify for participation. Additional supplementation to feeds beyond HM-derived fortifier (such as medium-chain triglycerides) is acceptable.
- Infants initially on intravenous nutrition will still be eligible for consent. Feed sample collections from these infants will commence once they advance to consume HM-based feeds once HM-derived fortifier is prescribed.
Who cannot join
- Infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded.
- Infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded.
- Non-English speaking subjects will be excluded as the team of study personnel includes those that speak English only.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU
The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. To do so, prospectively 100 infants receiving HM-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.
Read the detailed description
The purpose of this study is to determine if concentrations of these hormones in prepared HM feeds are associated with metabolic disturbances in the recipient infant. A prospectively study 100 infants receiving HM-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. Insulin and PTHrP will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control.
Hypothesis 1 Feed dose of insulin and PTHrP will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed.
Hypothesis 2: Over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving HM products.
- Conditions
- Premature Birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin concentration in prepared feeds
We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.
Measured: 3 months
Parathyroid hormone related protein (PTHrP) concentration in prepared feeds
We will measure final PTHrP concentrations in enteral feed preparations that contain some portion of human milk.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start16 Feb 2022
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget Young, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256927
- Sponsor's protocol ID
- STUDY00006851
- Other IDs
- 1R03DK131219
- Acronym
- MAGIC
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU
- ClinicalTrials.gov ID
- NCT05256927
- Acronym / sponsor ID
- MAGIC / STUDY00006851
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 25 Feb 2022 (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 determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. To do so, prospectively 100 infants receiving HM-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.
Detailed description
The purpose of this study is to determine if concentrations of these hormones in prepared HM feeds are associated with metabolic disturbances in the recipient infant. A prospectively study 100 infants receiving HM-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. Insulin and PTHrP will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control.
Hypothesis 1 Feed dose of insulin and PTHrP will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed.
Hypothesis 2: Over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving HM products.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | – |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants admitted to the University of Rochester Medical Center that are <30 weeks gestation and/or weigh <1250g at birth.
Key inclusion criteria (2 listed)
- Infants eligible to receive human milk (HM)-derived fortifiers. To qualify for these fortifiers, infants must be born <30 weeks gestation and/or weigh <1250g at birth. Enteral or oral feeding modes both qualify for participation. Additional supplementation to feeds beyond HM-derived fortifier (such as medium-chain triglycerides) is acceptable.
- Infants initially on intravenous nutrition will still be eligible for consent. Feed sample collections from these infants will commence once they advance to consume HM-based feeds once HM-derived fortifier is prescribed.
Key exclusion criteria (3 listed)
- Infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded.
- Infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded.
- Non-English speaking subjects will be excluded as the team of study personnel includes those that speak English only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insulin concentration in prepared feeds
Time frame: 3 months
We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.
Parathyroid hormone related protein (PTHrP) concentration in prepared feeds
Time frame: 3 months
We will measure final PTHrP concentrations in enteral feed preparations that contain some portion of human milk.
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 10 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University of Rochester 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 2 inclusion and 3 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 10 Mar 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?
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?
Insulin concentration in prepared feeds (time frame: 3 months). The study lists 2 primary outcomes in all. 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 10 Mar 2025.