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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01208493
First received: September 22, 2010
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison of feeding tolerance and metabolic status between study groups as a measure of safety [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2007
Estimated Study Completion Date: April 2012
Estimated 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

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208493

Locations
United States, Missouri
Department of Pediatrics St Louis University
Saint Louis, Missouri, United States, 63104
Belgium
Service Universitaire de Néonatologie CHR de la Citadelle
Liège, Belgium, 4000
France
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
Nestlé
Investigators
Principal Investigator: Richard J Cooke, MD Department of Pediatrics St Louis University
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01208493     History of Changes
Other Study ID Numbers: 04.26.INF
Study First Received: September 22, 2010
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
prematurity
enteral feeding
proteins
formula

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014