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

Not Applicable

Terminated

• Conditions: Prematurity
• Interventions: Other: preterm standard infant formula; Other: preterm infant formula with high protein levels

• Registration Number: NCT01208493
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control preterm formula	preterm standard infant formula	-
high protein preterm infant formula	preterm infant formula with high protein levels	preterm infant formula with high protein levels

Primary Outcome Measures

Name	Time	Method
comparison of weight gain between both study groups as a measure of safety	3 weeks

Secondary Outcome Measures

Name	Time	Method
comparison of feeding tolerance and metabolic status between study groups as a measure of safety	3 weeks

Trial Locations

Locations (4)

Service Universitaire de Néonatologie CHR de la Citadelle; 🇧🇪 Liège, Belgium

Department of Pediatrics St Louis University; 🇺🇸 Saint Louis, Missouri, United States

Service de néonatologie Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Department of Child Health Royal Victoria Infirmary; 🇬🇧 Newcastle upon Tyne, United Kingdom