N/A
N=120
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
Infant, Premature, Diseases · Infant, Small for Gestational Age
Bottom Line
View on ClinicalTrials.gov: NCT02372136 ↗Enrolled (actual)
120
Serious AEs
9.2%
Results posted
May 2021
Primary outcome: Primary: Growth Velocity — 13; 13.1 g kg-1 day-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individualized Nutrition (Dietary_supplement); Optimized nutrition (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Growth Velocity |
13; 13.1 | — |
| PRIMARY Linear Growth Velocity |
0.90; 0.91 | — |
| SECONDARY Disproportionate Growth (Increased Fat Mass): BMI >90th Centile |
1; 1 | — |
| SECONDARY Blood Pressure |
69.4; 69.7 | — |
| SECONDARY Hypertension or High Systolic Blood Pressure |
7; 3 | — |
| SECONDARY Neurodevelopment |
74; 74 | — |
| SECONDARY Neurodevelopment |
74; 74 | — |
| SECONDARY Leptin |
2.8; 1.9 | — |
| SECONDARY Renal Function |
.79; .83 | — |
| SECONDARY Comparison of Weight With Expected Value for Age and Gender |
-1.05; -1.18 | — |
| SECONDARY Comparison of Length With Expected Value for Age and Gender |
-1.48; -1.61 | — |
| SECONDARY Comparison of Head Size With Expected Value for Age and Gender |
-1.06; -1.24 | — |
| SECONDARY Rate of Weight Gain |
13; 13.1 | — |
| SECONDARY Rate of Linear Growth |
.9; .91 | — |
| SECONDARY Comparison of Rate of Head Growth With Expected Value for Age and Gender |
-.63; -.74 | — |
| SECONDARY Body Composition |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02372136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.