Is Milk Associated With Glycemia in the NICU

Premature Birth Clinical Trial

— MAGIC  

Official title:

Is Milk Associated With Glycemia in the NICU (MAGIC) A Study in the NICU

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05256927
• Other study ID #: STUDY00006851
• Secondary ID: 1R03DK131219
• Status: Active, not recruiting
• Start date: February 16, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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