Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
1 other identifier
interventional
120
1 country
1
Brief Summary
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses). The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, \<29 weeks) and in small for GA (SGA, birth weight \<10th percentile for GA) preterm infants compared with optimized nutrition. The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedResults Posted
Study results publicly available
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 3, 2024
June 1, 2024
8 years
February 12, 2015
March 5, 2021
June 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Growth Velocity
Rate of weight gain \[g x kg-1 x day-1\] and length velocity \[cm x week-1\]
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Linear Growth Velocity
Increase in body length per week from birth to 36 weeks postmenstrual age or discharge
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Secondary Outcomes (14)
Disproportionate Growth (Increased Fat Mass): BMI >90th Centile
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Blood Pressure
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Hypertension or High Systolic Blood Pressure
at 33-48 months adjusted age
Neurodevelopment
18-41 months adjusted age (postnatal age corrected for prematurity)
Neurodevelopment
18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months corrected age 18-41 months
- +9 more secondary outcomes
Other Outcomes (2)
Mortality
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Necrotizing Enterocolitis
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Study Arms (2)
Individualized and Optimized Nutrition
EXPERIMENTALIndividualized nutrition Optimized nutrition
Optimized Nutrition
OTHEROptimized nutrition
Interventions
Intake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis. In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas. In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91).
Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length).
Eligibility Criteria
You may qualify if:
- Preterm infants \<29 weeks GA and SGA infants \<35 weeks GA born at Parkland Health and Hospital System
- Maternal plan to breastfeed or to use milk from the donor milk bank
- From birth to 1 week of life
You may not qualify if:
- Patients on comfort care only
- Patients with major congenital abnormalities
- Patients who are too unstable for the first 7 days to have an accurate length measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- Children's Medical Center Dallascollaborator
- The Gerber Foundationcollaborator
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
Related Publications (3)
Brion LP, Rosenfeld CR, Heyne R, Brown LS, Lair CS, Petrosyan E, Jacob T, Caraig M, Burchfield PJ. Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial. J Perinatol. 2020 Apr;40(4):655-665. doi: 10.1038/s41372-020-0609-1. Epub 2020 Feb 18.
PMID: 32071367BACKGROUNDReis JD, Heyne R, Rosenfeld CR, Caraig M, Brown LS, Burchfield PJ, Lair CS, Petrosyan E, Jabob T, Nelson DB, Brion LP. Follow-up of a randomized trial optimizing neonatal nutrition in preterm very low birthweight infants: growth, serum adipokines, renal function and blood pressure. J Perinatol. 2024 Jan;44(1):78-86. doi: 10.1038/s41372-023-01821-2. Epub 2023 Nov 14.
PMID: 37964083DERIVEDReis JD, Tolentino-Plata K, Caraig M, Heyne R, Rosenfeld CR, Brown LS, Brion LP. Double-blinded randomized controlled trial of optimizing nutrition in preterm very low birth weight infants: Bayley scores at 18-38 months of age. J Perinatol. 2023 Jan;43(1):81-85. doi: 10.1038/s41372-022-01572-6. Epub 2022 Dec 6.
PMID: 36473929DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- National Grant Gerber Foundation) (LPB); George L. MacGregor Professorship (CRR); National Children'
- Organization
- Gerber Foundation, UT Southwestern Med Ctr, Children's Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Luc P Brion, MD
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Only the statistician and the formula technicians know the patients' allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 26, 2015
Study Start
January 1, 2016
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 3, 2024
Results First Posted
May 20, 2021
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- after completion and publication of all follow-up data
- Access Criteria
- on reasonable request
The datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request after completion and publication of all follow-up data.