Weight Gain
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTProtein fortifier
Protein Fortifier to be added to Fortified human milk according to feeding regimen
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days. * Birth weight less or equal to 1500 g * Minimum enteral intake of 150-160 mL/kg/d fortified HM * Parents, liable parent, or legal representative (LR) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry
Exclusion criteria
* Infants with weight z-score \< -2 SD, based on the Fenton growth chart (Fenton 2013) * Intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia. * Renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine. * Cholestasis (total bilirubin \> 5 mg/dL or 85 umol/L and direct bilirubin \> 20% of total bilirubin) associated with one or more abnormal liver function tests (AST, ALT, or GGT). * Major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.). * Suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.). * Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,: * NEC grade above or equal to 2 * Uncontrolled sepsis * Suspected or documented maternal substance abuse: * Born to mothers who smoked \> 10 cigarettes per day during pregnancy * Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy * Subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol * Infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of weight gain | From Day 6 to Day 27 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm) | Day 6 to Day 27 (minimum) | Changes in growth parameters: Lengths (crown-heel and knee-heel) and length gain (cm) |
| Changes in growth parameters: head circumference and head circumference gain (cm) | Day 6 to Day 27 (minimum) | Changes in growth parameters: head circumference and head circumference gain (cm) |
| Changes in growth parameters: BMI and BMI changes (kg body weight/m^2) | Day 6 to Day 27 (minimum) | Changes in growth parameters: BMI and BMI changes (kg body weight/m\^2) |
| Body composition including lean fat mass and fat-free mass | Day 6 to Day 27 (minimum) | Body composition including lean fat mass and fat-free mass |
| 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 | Day 6 to Day 13, and 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 HM fortification |
| Macronutrient content in human milk | Day 6 to Day 27 (minimum) | Macronutrient content in human milk using a Miris Human Milk Analyzer to measure the composition of the human milk |
| Feeding and gastrointestinal (GI) tolerance | Day 6 to Day 27 (minimum) | 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 |
| Safety evaluation including number of subjects with AEs | Day 1 to Day 27 (minimum) | Safety evaluation including number of subjects with AEs |
| Biochemistry markers collected from blood and urine as part of routine NICU standard of care | Day 6 to Day 27 (minimum) | 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 |
| Weight at hospital discharge | Day 27 (minimum) | Weight at hospital discharge |
Countries
France
Outcome results
None listed