Prematurity Clinical Trial
Official title:
Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance
Verified date | December 2011 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 70 |
Est. completion date | April 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 10 Weeks |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Service Universitaire de Néonatologie CHR de la Citadelle | Liège | |
France | Service de néonatologie Hôpital de la Croix Rousse | Lyon | |
United Kingdom | Department of Child Health Royal Victoria Infirmary | Newcastle upon Tyne | |
United States | Department of Pediatrics St Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
United States, Belgium, France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison of weight gain between both study groups as a measure of safety | 3 weeks | No | |
Secondary | comparison of feeding tolerance and metabolic status between study groups as a measure of safety | 3 weeks | No |
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