Is Milk Associated with Glycemia in the NICU

NCT05256927 | Completed

• 2 other identifiers: STUDY000068511R03DK131219
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

All Participants

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: February 16, 2022
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)