Prematurity
Conditions
Keywords
prematurity, enteral feeding, proteins, formula
Brief summary
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula. Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed. After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.
Interventions
OTHERpreterm infant formula with high protein levels
minimum 3 weeks feeding until hospital discharge
OTHERpreterm standard infant formula
minimum 3 weeks feeding until hospital discharge
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Gestational age \<32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof * Birth weight ≤1500 g * Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h * Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved * In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl * Written informed consent has been obtained from the legal representative
Exclusion criteria
* Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days * Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography * Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine * Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture * Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3) * Hepatic dysfunction: defined by jaundice (direct bilirubin \>1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT) * Lung disease, severe enough to require steroid therapy. * Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age. * Participation in another clinical trial that may affect outcomes of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of weight gain between both study groups as a measure of safety | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| comparison of feeding tolerance and metabolic status between study groups as a measure of safety | 3 weeks |
Countries
Belgium, France, United Kingdom, United States
Outcome results
None listed