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Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372136
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Children's Medical Center Dallas
The Gerber Foundation
Information provided by (Responsible Party):
Luc P. Brion, MD, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Infant, Premature, Diseases Infant, Small for Gestational Age Dietary Supplement: Individualized Nutrition Dietary Supplement: Optimized nutrition Not Applicable

Detailed Description:

Hypotheses:

  1. 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.
  2. 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:

  1. 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).
  2. 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the statistician and the formula technicians know the patients' allocation.
Primary Purpose: Treatment
Official Title: Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
Study Start Date : January 2016
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Experimental: Individualized and Optimized Nutrition
Individualized nutrition Optimized nutrition
Dietary Supplement: Individualized Nutrition

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 Name: Targeted, customized

Dietary Supplement: 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 (corrected for serum creatinine level) and albumin and velocity of growth (weight and length).
Other Name: Adjustable

Optimized Nutrition
Optimized nutrition
Dietary Supplement: 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 (corrected for serum creatinine level) and albumin and velocity of growth (weight and length).
Other Name: Adjustable




Primary Outcome Measures :
  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]


Secondary Outcome Measures :
  1. Disproportionate growth (increased fat mass) [ Time Frame: 36 weeks postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Ratio of subscapular skinfold to abdominal circumference, ponderal index, body mass index, mid-arm circumference and Z-scores

  2. Blood pressure [ Time Frame: At 36 weeks postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively) and at 1-3 years of age ]
    Systolic blood pressure (calm or sleeping)

  3. Hypertension and high blood pressure [ Time Frame: At 36 weeks postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively) and at 1-3 years of age ]
    Systolic blood pressure, as defined by the SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN (Flynn JT, Kaelber DC, Baker-Smith CM, et al. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017;140(3):e20171904)

  4. Neurodevelopment [ Time Frame: 18-26 months adjusted age (postnatal age corrected for prematurity) ]
    Bayley III: cognitive composite and language scores

  5. Assessment of biomarkers of adiposity [ Time Frame: at 1-3 years of age ]
    Serum levels of adipokines: leptin, adiponectin and resistin

  6. Assessment of renal glomerular function [ Time Frame: at 1-3 years of age ]
    Serum level of cystatin C

  7. Comparison of weight with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Z score for weight

  8. Comparison of length with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Z score for length

  9. Comparison of head size with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Z score for fronto-occipital circumference

  10. Comparison of rate of weight gain with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Change in z score for weight from birth to time frame

  11. Comparison of rate of linear growth with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Change in z score for length from birth to time frame

  12. Comparison of rate of head growth with expected value for age and gender [ Time Frame: at 36 weeks of Postmenstrual age, within 24 hours of discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively), and at 1-3 years of age ]
    Change in z score for fronto-occipital circumference from birth to time frame

  13. Body composition [ Time Frame: at 1 year of age and 3 years of age ]
    Percent fat mass measured by Dexascan

  14. Microbiome [ Time Frame: Weekly until discharge from the neonatal intensive care unit ]
    Stool microbiome analysis by next generation sequencing and quantitative real time PCR


Other Outcome Measures:
  1. Mortality [ Time Frame: Until discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively) and by 3 years ]
    Percent of infants who died from birth to discharge from the neonatal intensive care unit

  2. Necrotizing enterocolitis [ Time Frame: Until discharge from the neonatal intensive care unit (expected average postmenstrual age 40, 45 and 38 weeks for AGA 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks, respectively) ]
    Percentage of infants who developed necrotizing enterocolitis stage II or greater (using the modified Bell stage classification) in the neonatal intensive care unit



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372136


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9063
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
The Gerber Foundation
Investigators
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Principal Investigator: Luc P Brion, MD UT Southwestern Medical Center

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Responsible Party: Luc P. Brion, MD, Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02372136    
Other Study ID Numbers: STU 102014-056
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Infant, Premature, Diseases
Infant, Newborn, Diseases