Preterm Birth
Conditions
Keywords
Nutrition, Body Composition, Preterm, Neonate
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.
Interventions
OTHEREnhanced Intravenous Nutrition
Increased macronutrients for first 7 days
OTHERStandard Intravenous Nutrition
Standard macronutrients for first 7 days
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed