Enhanced Nutrition for Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Infants will be randomized to receive either standard parenteral nutrition via the 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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.

Study Groups

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Enhanced Nutrition

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.

Group Type EXPERIMENTAL

Enhanced Intravenous Nutrition

Intervention Type OTHER

Increased macronutrients for first 7 days

Standard Nutrition

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.

Group Type ACTIVE_COMPARATOR

Standard Intravenous Nutrition

Intervention Type OTHER

Standard macronutrients for first 7 days

Interventions

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Enhanced Intravenous Nutrition

Increased macronutrients for first 7 days

Intervention Type OTHER

Standard Intravenous Nutrition

Standard macronutrients for first 7 days

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No