Trial Outcomes & Findings for Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants (NCT NCT02372136)
NCT ID: NCT02372136
Last Updated: 2024-07-03
Results Overview
Rate of weight gain \[g x kg-1 x day-1\] and length velocity \[cm x week-1\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Results posted on
2024-07-03
Participant Flow
Preterm neonates born at Parkland Hospital between January 27, 2016 and September 10, 2018
Neonates were excluded if they received comfort care only, had a major congenital abnormality, or were too unstable for the first 7 days to have an accurate length measurement using a length board or a caliper.
Participant milestones
| Measure |
Individualized and Optimized Nutrition
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
Optimized nutrition
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).
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
|
Overall Study
COMPLETED
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Individualized and Optimized Nutrition
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
Optimized nutrition
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).
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
Baseline Characteristics
Accurate validated birth length was not obtained in 4 newborns.
Baseline characteristics by cohort
| Measure |
Individualized and Optimized Nutrition
n=62 Participants
Both individualized and optimized nutrition
|
Optimized Nutrition
n=58 Participants
Optimized nutrition only
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 weeks
STANDARD_DEVIATION 3 • n=62 Participants
|
28 weeks
STANDARD_DEVIATION 3 • n=58 Participants
|
28 weeks
STANDARD_DEVIATION 3 • n=120 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=62 Participants
|
33 Participants
n=58 Participants
|
64 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=62 Participants
|
25 Participants
n=58 Participants
|
56 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=62 Participants
|
39 Participants
n=58 Participants
|
80 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=62 Participants
|
19 Participants
n=58 Participants
|
40 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=62 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=62 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=62 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=62 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=62 Participants
|
17 Participants
n=58 Participants
|
34 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=62 Participants
|
40 Participants
n=58 Participants
|
85 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=62 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=62 Participants
|
1 Participants
n=58 Participants
|
1 Participants
n=120 Participants
|
|
Birth weight
|
1024 grams
STANDARD_DEVIATION 304 • n=62 Participants
|
1034 grams
STANDARD_DEVIATION 294 • n=58 Participants
|
1029 grams
STANDARD_DEVIATION 299 • n=120 Participants
|
|
Birth length
|
35.6 cm
STANDARD_DEVIATION 3.6 • n=59 Participants • Accurate validated birth length was not obtained in 4 newborns.
|
35.5 cm
STANDARD_DEVIATION 3.4 • n=57 Participants • Accurate validated birth length was not obtained in 4 newborns.
|
35.6 cm
STANDARD_DEVIATION 3.5 • n=116 Participants • Accurate validated birth length was not obtained in 4 newborns.
|
|
Birth fronto-occipital circumference
|
24.7 cm
STANDARD_DEVIATION 2.4 • n=62 Participants
|
24.9 cm
STANDARD_DEVIATION 2.5 • n=58 Participants
|
24.8 cm
STANDARD_DEVIATION 2.4 • n=120 Participants
|
PRIMARY outcome
Timeframe: 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 \[cm x week-1\]
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=59 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=57 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Growth Velocity
|
13 g kg-1 day-1
Standard Deviation 2.6
|
13.1 g kg-1 day-1
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Data were not available for patients transferred to another institution
Increase in body length per week from birth to 36 weeks postmenstrual age or discharge
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=52 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=55 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Linear Growth Velocity
|
0.90 cm per week
Standard Deviation 0.23
|
0.91 cm per week
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Total number is limited by need for accurate validated length and weight on the same day. This was not available in patients who were transferred.
Disproportionate growth (increased fat mass): BMI \> 90th centile for sex and age
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=50 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=55 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Disproportionate Growth (Increased Fat Mass): BMI >90th Centile
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Systolic blood pressure (calm or sleeping)
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=50 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=50 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Blood Pressure
|
69.4 mm Hg
Standard Deviation 7.2
|
69.7 mm Hg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: at 33-48 months adjusted agePopulation: 33-48 months adjusted age Not all participants entered follow-up and had data collected.
Systolic blood pressure \>90th centile defined by the SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=40 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=38 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Hypertension or High Systolic Blood Pressure
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 18-41 months adjusted age (postnatal age corrected for prematurity)Population: BSID-III assessment was performed at 18-38 months of age corrected for prematurity, scored for corrected age, and adjusted for age of administration
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
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=47 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=44 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Neurodevelopment
|
85 score on a scale
Interval 75.0 to 90.0
|
85 score on a scale
Interval 75.0 to 90.0
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: BSID-III assessment was performed at 18-38 months of age corrected for prematurity, scored for corrected age, and adjusted for age of administration.
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
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=47 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=44 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Neurodevelopment
|
74 score on a scale
Interval 68.0 to 84.0
|
74 score on a scale
Interval 68.0 to 89.0
|
SECONDARY outcome
Timeframe: 33-48 months adjusted agePopulation: 33-48 months adjusted age Not all participants entered follow-up and had data collected.
Serum levels of leptin (measure of adiposity)
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=33 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=28 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Leptin
|
2.8 ng/ml
Standard Error 0.48
|
1.9 ng/ml
Standard Error 0.32
|
SECONDARY outcome
Timeframe: 33-48 months adjusted agePopulation: 33-48 months adjusted age Not all participants entered follow-up and had data collected.
Serum level of cystatin C. This value increases if renal glomerular filtration decreases.
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=36 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=32 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Renal Function
|
.79 mg/dl
Standard Deviation .14
|
.83 mg/dl
Standard Deviation .14
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Not all participants entered follow-up and had data collected.
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.
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=59 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=57 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Comparison of Weight With Expected Value for Age and Gender
|
-1.05 Z-score
Standard Deviation .9
|
-1.18 Z-score
Standard Deviation .8
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Not all participants entered follow-up and had data collected.
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.
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=52 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=55 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Comparison of Length With Expected Value for Age and Gender
|
-1.48 Z-score
Standard Deviation 0.9
|
-1.61 Z-score
Standard Deviation .9
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Not all participants entered follow-up and had data collected.
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.
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=58 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=57 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Comparison of Head Size With Expected Value for Age and Gender
|
-1.06 Z-score
Standard Deviation 1
|
-1.24 Z-score
Standard Deviation .9
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Not all participants entered follow-up and had data collected.
Rate of weight gain
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=59 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=57 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Rate of Weight Gain
|
13 g/kg/day
Standard Deviation 2.6
|
13.1 g/kg/day
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Rate of linear growth
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=52 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=55 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Rate of Linear Growth
|
.9 cm/week
Standard Deviation .23
|
.91 cm/week
Standard Deviation .18
|
SECONDARY outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Not all participants entered follow-up and had data collected.
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.
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=58 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=57 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Comparison of Rate of Head Growth With Expected Value for Age and Gender
|
-.63 Z-score
Standard Deviation 1
|
-.74 Z-score
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: at 1 year of age and 3 years of agePercent fat mass measured by Dexascan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=62 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=58 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Mortality
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)Population: Until 36 weeks postmenstrual age or discharge from the neonatal intensive care unit if earlier than 36 weeks
Percentage of infants who developed necrotizing enterocolitis stage II or greater (using the modified Bell stage classification) in the neonatal intensive care unit
Outcome measures
| Measure |
Individualized and Optimized Nutrition
n=62 Participants
Individualized nutrition Optimized nutrition
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).
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).
|
Optimized Nutrition
n=58 Participants
Optimized nutrition
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).
|
|---|---|---|
|
Necrotizing Enterocolitis
|
6 Participants
|
5 Participants
|
Adverse Events
Experimental
Serious events: 6 serious events
Other events: 19 other events
Deaths: 3 deaths
Control
Serious events: 5 serious events
Other events: 17 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Experimental
n=62 participants at risk
Optimized and individualized nutrition
|
Control
n=58 participants at risk
Optimized nutrition
|
|---|---|---|
|
Gastrointestinal disorders
Necrotizing enterocolitis
|
9.7%
6/62 • Number of events 62 • from birth to discharge from the neonatal intensive care unit
|
8.6%
5/58 • Number of events 58 • from birth to discharge from the neonatal intensive care unit
|
Other adverse events
| Measure |
Experimental
n=62 participants at risk
Optimized and individualized nutrition
|
Control
n=58 participants at risk
Optimized nutrition
|
|---|---|---|
|
Gastrointestinal disorders
Feeding intolerance
|
30.6%
19/62 • Number of events 62 • from birth to discharge from the neonatal intensive care unit
|
29.3%
17/58 • Number of events 58 • from birth to discharge from the neonatal intensive care unit
|
Additional Information
National Grant Gerber Foundation) (LPB); George L. MacGregor Professorship (CRR); National Children'
Gerber Foundation, UT Southwestern Med Ctr, Children's Medical Center
Phone: 214-648-3903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place