Status:
COMPLETED
Is Milk Associated with Glycemia in the NICU
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Premature Birth
Eligibility:
All Genders
Up to 3 years
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, prospe...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT05256927
Start Date
February 16 2022
End Date
March 10 2024
Last Update
March 10 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642