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Is Milk Associated With Glycemia in the NICU — MAGIC  

Premature Birth Clinical Trial

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

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05256927
Study type Observational
Source University of Rochester
Contact
Status Active, not recruiting
Phase
Start date February 16, 2022
Completion date February 28, 2025
View Details
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