Enhanced Nutrition for Preterm Infants

University of Minnesota80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Preterm Birth

Interventions

Enhanced Intravenous NutritionOTHER

Increased macronutrients for first 7 days

Standard Intravenous NutritionOTHER

Standard macronutrients for first 7 days

Eligibility

Sex: ALLMax age: 30 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States

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.

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

Time frame: 1 week

Data from ClinicalTrials.gov

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