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Enhanced Nutrition for Preterm Infants

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ClinicalTrials.gov Identifier: NCT03238768
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Other: Enhanced Intravenous Nutrition Other: Standard Intravenous Nutrition Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking Description: Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
Primary Purpose: Health Services Research
Official Title: Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: 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.
Other: Enhanced Intravenous Nutrition
Increased macronutrients for first 7 days

Active Comparator: 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.
Other: Standard Intravenous Nutrition
Standard macronutrients for first 7 days




Primary Outcome Measures :
  1. 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. [ Time Frame: 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



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Ages Eligible for Study:   up to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238768


Contacts
Contact: Mary Pat Osborne, RN 612-624-0581 marypat@umn.edu

Locations
United States, Minnesota
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Mary Pat Osborne, RN    612-624-0581    marypat@umn.edu   
Contact       sramel@umn.edu   
Principal Investigator: Sara E Ramel, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sara E Ramel, MD University of Minnesota Masonic Children's Hospital
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:
Informed Consent Form  [PDF] July 18, 2017


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03238768     History of Changes
Other Study ID Numbers: Ethos00000063
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Nutrition
Body Composition
Preterm
Neonate

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications