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

This study has been terminated.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: September 22, 2010
Last updated: March 25, 2015
Last verified: December 2011

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.

Condition Intervention
Prematurity Other: preterm infant formula with high protein levels Other: preterm standard infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

Resource links provided by NLM:

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • comparison of weight gain between both study groups as a measure of safety [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • comparison of feeding tolerance and metabolic status between study groups as a measure of safety [ Time Frame: 3 weeks ]

Enrollment: 70
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01208493

United States, Missouri
Department of Pediatrics St Louis University
Saint Louis, Missouri, United States, 63104
Service Universitaire de Néonatologie CHR de la Citadelle
Liège, Belgium, 4000
Service de néonatologie Hôpital de la Croix Rousse
Lyon, France, 69317
United Kingdom
Department of Child Health Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Principal Investigator: Richard J Cooke, MD Department of Pediatrics St Louis University
  More Information

Responsible Party: Nestlé Identifier: NCT01208493     History of Changes
Other Study ID Numbers: 04.26.INF
Study First Received: September 22, 2010
Last Updated: March 25, 2015

Keywords provided by Nestlé:
enteral feeding

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on July 19, 2017