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

NCT01208493 | Terminated DMC

• 1 other identifier: 04.26.INF
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 4

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.

Conditions

Prematurity

Keywords

prematurity; enteral feeding; proteins; formula

Outcome Measures

Primary Outcomes (1)

• comparison of weight gain between both study groups as a measure of safety

  3 weeks

Secondary Outcomes (1)

• comparison of feeding tolerance and metabolic status between study groups as a measure of safety

  3 weeks

Study Arms (2)

high protein preterm infant formula

EXPERIMENTAL

preterm infant formula with high protein levels

Other: preterm infant formula with high protein levels

control preterm formula

ACTIVE COMPARATOR

Other: preterm standard infant formula

Interventions

preterm infant formula with high protein levels OTHER

minimum 3 weeks feeding until hospital discharge

high protein preterm infant formula

preterm standard infant formula OTHER

minimum 3 weeks feeding until hospital discharge

control preterm formula

Eligibility Criteria

• Age: 1 Day - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (4)

Department of Pediatrics St Louis University

St Louis, Missouri, 63104, United States

Location

Service Universitaire de Néonatologie CHR de la Citadelle

Liège, 4000, Belgium

Location

Service de néonatologie Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Department of Child Health Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Richard J Cooke, MD

  Department of Pediatrics St Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 26, 2015

Record last verified: 2011-12

Locations

BE (1); GB (1); FR (1); US (1)