University of Rochester Medical Center
Rochester, New York, 14642, United States
NCT Number: NCT05256927
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.
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All sexes
Observational
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.
Time frame: 3 months
We will measure final PTHrP concentrations in enteral feed preparations that contain some portion of human milk.
University of Rochester
Other
Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU
Acronym: MAGIC
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