The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
68
Protein Fortifier to be added to Fortified human milk according to feeding regimen
Hopital de la Croix Rousse
Lyon, France
Comparison of weight gain
To compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a BUN-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen
Time frame: From Day 6 to Day 27
Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard Human Milk (HM) fortification
Comparison of weight gain (g/day) of infants after 1 and 3 weeks of individualized protein fortification to weight gain during the 5-day period of standard HM fortification
Time frame: Day 6 to Day 13, and Day 6 to Day 27
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm)
Time frame: Day 6 to Day 27 (minimum)
Changes in growth parameters: head circumference and head circumference gain (cm)
Changes in growth parameters: head circumference and head circumference gain (cm)
Time frame: Day 6 to Day 27 (minimum)
Changes in growth parameters: BMI and BMI changes (kg body weight/m^2)
Changes in growth parameters: BMI and BMI changes (kg body weight/m\^2)
Time frame: Day 6 to Day 27 (minimum)
Body composition including lean fat mass and fat-free mass
Body composition including lean fat mass and fat-free mass
Time frame: Day 6 to Day 27 (minimum)
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Weight at hospital discharge
Weight at hospital discharge
Time frame: Day 27 (minimum)
Macronutrient content in human milk
Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk
Time frame: Day 6 to Day 27 (minimum)
Feeding and gastrointestinal (GI) tolerance
Feeding and gastrointestinal (GI) tolerance determined using Digestive tolerance scores based on four binary parameters (0 = absence or 1 = presence) collected in daily routine care: Sore abdomen, liquid stools, gastric residuals, and regurgitation or vomiting
Time frame: Day 6 to Day 27 (minimum)
Safety evaluation including number of subjects with AEs
Safety evaluation including number of subjects with AEs
Time frame: Day 1 to Day 27 (minimum)
Biochemistry markers collected from blood and urine as part of routine NICU standard of care
Biochemistry markers collected from blood and urine as part of routine NICU standard of care: Routine biochemistries in Blood/Serum and Urine (in spot urine samples), and Nutrition markers in Blood/serum: albumin, pre-albumin, alkaline phosphatase, triglycerides and vitamin D
Time frame: Day 6 to Day 27 (minimum)