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

Société des Produits Nestlé (SPN)4 sites in 4 countries70 target enrollmentSeptember 2007

ConditionsPrematurity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prematurity
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 70
Locations: 4
Primary Endpoint: comparison of weight gain between both study groups as a measure of safety
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

April 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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