Enhanced Nutrition for Preterm Infants

University of Minnesota (UMN)

Status: Completed

Conditions: Preterm Birth

Treatments: Other: Standard Intravenous Nutrition; Other: Enhanced Intravenous Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03238768

STUDY00000063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 30 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Enhanced Nutrition

Experimental group

Description:

Infants randomized to the study protocol will start on higher initial amounts of calories, proteins and fats. They will also undergo faster increases of these nutrients during their first week of life.

Treatment:

Other: Enhanced Intravenous Nutrition

Standard Nutrition

Active Comparator group

Description:

Infants randomized to the standard nutrition protocol will start on standard amounts of calories, proteins and fats per the usual NICU routine. They will also undergo standard increases of these nutrients during their first week of life.

Treatment:

Other: Standard Intravenous Nutrition