NCT05256927

Is Milk Associated with Glycemia in the NICU

Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 0 Days – 3 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-03-10
• Completion: 2024-03-10
• First posted: 2022-02-25
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States