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Clinical Trials/NCT03238768
NCT03238768
Completed
Not Applicable

Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk

University of Minnesota1 site in 1 country80 target enrollmentAugust 15, 2017
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
University of Minnesota
Enrollment
80
Locations
1
Primary Endpoint
The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life.
Status
Completed
Last Updated
6 years ago

Overview

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 first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.

Registry
clinicaltrials.gov
Start Date
August 15, 2017
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Outcomes

Primary Outcomes

The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life.

Time Frame: 1 week

We will calculate the actual amount of protein, kcals, lipids etc received in both groups at the end of the first week to determine if we were able to deliver increased amounts of nutrition to the enhanced protocol group

Study Sites (1)

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