Enhanced Nutrition for Preterm Infants

Preterm Birth Clinical Trial

Official title:

Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238768
• Other study ID #: STUDY00000063
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Enhanced Intravenous Nutrition
Increased macronutrients for first 7 days
• Standard Intravenous Nutrition
Standard macronutrients for first 7 days

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week