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

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

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.

Study Overview

• Status: Terminated
• Conditions: Prematurity
• Intervention / Treatment: Other: preterm infant formula with high protein levels; Other: preterm standard infant formula

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Service Universitaire de Néonatologie CHR de la Citadelle
• France
  • Lyon, France, 69317
    • Service de néonatologie Hôpital de la Croix Rousse
• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Department of Child Health Royal Victoria Infirmary
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Department of Pediatrics St Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high protein preterm infant formula; preterm infant formula with high protein levels	Other: preterm infant formula with high protein levels; minimum 3 weeks feeding until hospital discharge
Active Comparator: control preterm formula	Other: preterm standard infant formula; minimum 3 weeks feeding until hospital discharge

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Richard J Cooke, MD, Department of Pediatrics St Louis University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: September 23, 2010
• First Posted (Estimate): September 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: enteral feeding; prematurity; formula; proteins
• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Birth Weight
• Other Study ID Numbers: 04.26.INF