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

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ClinicalTrials.gov Identifier: NCT01208493
Recruitment Status : Terminated
First Posted : September 24, 2010
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.


Condition or disease Intervention/treatment Phase
Prematurity Other: preterm infant formula with high protein levels Other: preterm standard infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


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Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01208493     History of Changes
Other Study ID Numbers: 04.26.INF
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: December 2011

Keywords provided by Nestlé:
prematurity
enteral feeding
proteins
formula

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications