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Enhanced Nutrition for Preterm Infants

University of Minnesota (UMN) logo

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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