Enhanced Nutrition for Preterm Infants

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Other: Enhanced Intravenous Nutrition; Other: Standard Intravenous Nutrition

• Registration Number: NCT03238768
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Study Start: 2017-08-15
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Nutrition	Enhanced Intravenous 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.
Standard Nutrition	Standard Intravenous 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.

Primary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

University of Minnesota Masonic Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States