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

Stopped early · Not applicable

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT01208493

Run by

Société des Produits Nestlé (SPN)

People needed

70

Starts

2007-09-01

Expected to finish

2012-04-01

Last updated by the study team

2015-03-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Pediatrics St Louis University — St Louis, Missouri, United States
• Service Universitaire de Néonatologie CHR de la Citadelle — Liège, Belgium
• Service de néonatologie Hôpital de la Croix Rousse — Lyon, France
• Department of Child Health Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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