Skip to main content
OpenTrials
Completed

NCT Number: NCT02372136

Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Small for Gestational Age

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-9063, United States

About this study

Hypotheses:

  • Primary hypothesis: In preterm infants (GA <29 weeks or GA <35 weeks and SGA) individualized and optimized nutrition will increase velocity of growth (weight gain velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36 weeks of postmenstrual age (GA plus postnatal age) or discharge (whichever comes first) in comparison with optimized nutrition.
  • Secondary hypotheses: Individualized and optimized nutrition will improve neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.

Study design:

Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be randomized to one of two groups.

Study intervention: Patients will be randomized to either:

  • Control: optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen and albumin and velocity of growth (weight and length).
  • Intervention: Individualized and optimized nutrition: Milk fortification will be optimized as in control neonates. In addition, nutrition will be individualized every day. Milk fortification will be adjusted based on daily measurements of macronutrients in human milk using near-infrared analysis.

Randomization will be done by computer provided by a statistician using random block allocation and stratification by GA and size for age (AGA [appropriate for GA] 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks). Twins and multiples will be randomized to the same arm of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized Nutrition

Dietary Supplement

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).

Other names: Targeted, customized

Optimized nutrition

Dietary Supplement

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).

Other names: Adjustable

Primary outcomes

  1. Growth Velocity

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Rate of weight gain [g x kg-1 x day-1] and length velocity [cm x week-1]

  2. Linear Growth Velocity

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Increase in body length per week from birth to 36 weeks postmenstrual age or discharge

Secondary outcomes

  1. Disproportionate Growth (Increased Fat Mass): BMI >90th Centile

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Disproportionate growth (increased fat mass): BMI > 90th centile for sex and age

  2. Blood Pressure

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Systolic blood pressure (calm or sleeping)

  3. Hypertension or High Systolic Blood Pressure

    Time frame: at 33-48 months adjusted age

    Systolic blood pressure >90th centile defined by the SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN

  4. Neurodevelopment

    Time frame: 18-41 months adjusted age (postnatal age corrected for prematurity)

    Bayley Scale of Infant and Toddler Development, Third Edition (BSID-III): cognitive composite score Higher scores mean a better outcome. The composite scaled score has a mean of 100 and a SD of 15, a floor of 55 and a ceiling of 145.

    Bayley, N. (2006). Bayley Scales of Infant and Toddler Development- Third Edition. San Antonio, TX: Harcourt Assessment.

    DOI: 10.1177/0734282906297199

  5. Neurodevelopment

    Time frame: 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

    Bayley Scale of Infant and Toddler Development, Third Edition (BSID-III): language composite score Higher scores mean a better outcome. The composite scaled score has a mean of 100 and a SD of 15, a floor of 47 and a ceiling of 153.

    Bayley, N. (2006). Bayley Scales of Infant and Toddler Development- Third Edition. San Antonio, TX: Harcourt Assessment.

    DOI: 10.1177/0734282906297199

  6. Leptin

    Time frame: 33-48 months adjusted age

    Serum levels of leptin (measure of adiposity)

  7. Renal Function

    Time frame: 33-48 months adjusted age

    Serum level of cystatin C. This value increases if renal glomerular filtration decreases.

  8. Comparison of Weight With Expected Value for Age and Gender

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Comparison of weight with expected value for age and gender: Z score for weight Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero with concomitant zero for length.

  9. Comparison of Length With Expected Value for Age and Gender

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Comparison of length with expected value for age and gender: Z score for length Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero with concomitant zero for weight.

  10. Comparison of Head Size With Expected Value for Age and Gender

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Comparison of head size with expected value for age and gender: Z score for fronto-occipital circumference Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero.

  11. Rate of Weight Gain

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Rate of weight gain

  12. Rate of Linear Growth

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Rate of linear growth

  13. Comparison of Rate of Head Growth With Expected Value for Age and Gender

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Change in z score for fronto-occipital circumference from birth to endpoint Expected mean for age and gender is zero. Normal is -2 to +2.

  14. Body Composition

    Time frame: at 1 year of age and 3 years of age

    Percent fat mass measured by Dexascan

Other outcomes

  1. Mortality

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Percent of infants who died from birth to endpoint (36 weeks post menstrual age or discharge from the neonatal intensive care unit if earlier than 36 weeks)

  2. Necrotizing Enterocolitis

    Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)

    Percentage of infants who developed necrotizing enterocolitis stage II or greater (using the modified Bell stage classification) in the neonatal intensive care unit

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Children's Medical Center Dallas
  • The Gerber Foundation

Registry information

Official study title

Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2015
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.