Is Milk Associated with Glycemia in the NICU | NCT05256927

Studies
Is Milk Associated with Glycemia in the NICU

NCT05256927

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Mar 10, 2025Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Premature Birth

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R03DK131219	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2022Actual

Primary Completion Date

Mar 10, 2024Actual

Completion Date

Mar 10, 2024Actual

First Submitted Date

Feb 16, 2022

First Submission Date that Met QC Criteria

Feb 16, 2022

First Posted Date

Feb 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2025

Last Update Posted Date

Mar 10, 2025Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Label	Type	Description	Intervention Names
All Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin concentration in prepared feeds	We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.	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.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

3 Months

Standard Ages

Child

Study Population

Premature infants admitted to the University of Rochester Medical Center that are <30 weeks gestation and/or weigh <1250g at birth.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center		Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

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