Dietary Protein in the Very-low-birth-weight Infant

Study Overview
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Brief Summary
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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.

Official Title
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Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

Conditions
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Prematurity

Intervention / Treatment
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* Other: preterm infant formula with high protein levels
* Other: preterm standard infant formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high protein preterm infant formula<br>preterm infant formula with high protein levels | Other: preterm infant formula with high protein levels<br>* minimum 3 weeks feeding until hospital discharge<br>|
| Active Comparator: control preterm formula<br> | Other: preterm standard infant formula<br>* minimum 3 weeks feeding until hospital discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of weight gain between both study groups as a measure of safety |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of feeding tolerance and metabolic status between study groups as a measure of safety |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, enteral feeding, proteins, formula