Back to resultsEnhanced Nutrition for Preterm Infants
Primary Purpose
Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Intravenous Nutrition
Standard Intravenous Nutrition
Sponsored by
About this trial
This is an interventional health services research trial for Preterm Birth focused on measuring Nutrition, Body Composition, Preterm, Neonate
Eligibility Criteria
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.
Sites / Locations
- University of Minnesota Masonic Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced Nutrition
Standard Nutrition
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03238768
First Posted
July 25, 2017
Last Updated
October 28, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03238768
Brief Title
Enhanced Nutrition for Preterm Infants
Official Title
Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Nutrition, Body Composition, Preterm, Neonate
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Nutrition
Arm Type
Experimental
Arm 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.
Arm Title
Standard Nutrition
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Enhanced Intravenous Nutrition
Intervention Description
Increased macronutrients for first 7 days
Intervention Type
Other
Intervention Name(s)
Standard Intravenous Nutrition
Intervention Description
Standard macronutrients for first 7 days
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara E Ramel, MD
Organizational Affiliation
University of Minnesota Masonic Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhanced Nutrition for Preterm Infants
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