Enhanced Nutrition for Preterm Infants

NCT03238768 | Completed DMC

• 1 other identifier: STUDY00000063
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Nutrition; Body Composition; Preterm; Neonate

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Enhanced Nutrition

EXPERIMENTAL

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

Standard Nutrition

ACTIVE COMPARATOR

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

Interventions

Enhanced Intravenous Nutrition OTHER

Increased macronutrients for first 7 days

Enhanced Nutrition

Standard Intravenous Nutrition OTHER

Standard macronutrients for first 7 days

Standard Nutrition

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Nagel EM, Gonzalez V JD, Bye JK, Super J, Demerath EW, Ramel SE. Enhanced Parenteral Nutrition Is Feasible and Safe in Very Low Birth Weight Preterm Infants: A Randomized Trial. Neonatology. 2023;120(2):242-249. doi: 10.1159/000527552. Epub 2023 Feb 22.

  PMID: 36812894 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sara E Ramel, MD

  University of Minnesota Masonic Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 3, 2017
• Study Start: August 15, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)