Status:
COMPLETED
Enhanced Nutrition for Preterm Infants
Lead Sponsor:
University of Minnesota
Conditions:
Preterm Birth
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief Summary
The overall objective of the proposal is to demonstrate the feasibility of providing increased calories and protein in the first week of life to very low birth weight (VLBW) preterm infants.
Detailed Description
Infants will be randomized to receive either standard parenteral nutrition via the neonatal intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol during their fir...
Eligibility Criteria
Inclusion
- VLBW (birth weight \<1500grams) preterm (gestational age (GA) at birth \< 32 weeks) infants admitted to the University of Minnesota Masonic Children's Hospital NICU, for which written informed consent can be secured from a parent within 12 hours of birth.
Exclusion
- Infants who are diagnosed prenatally with a clinical condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development, who experienced severe birth asphyxia, who are enrolled in another study affecting nutritional management, or who are likely to be transferred out of the NICU will be excluded from participation.
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03238768
Start Date
August 15 2017
End Date
July 31 2019
Last Update
October 29 2019
Active Locations (1)
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1
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454