Clinical trial NCT05256927: Is Milk Associated with Glycemia in the NICU
Official title: Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-25
Enrollment: 124
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin concentration in prepared feeds
timeFrame: 3 months
measure: Parathyroid hormone related protein (PTHrP) concentration in prepared feeds
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: