Status:
TERMINATED
Dietary Protein in the Very-low-birth-weight Infant
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Prematurity
Eligibility:
All Genders
1-10 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01208493
Start Date
September 1 2007
End Date
April 1 2012
Last Update
March 26 2015
Active Locations (4)
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1
Department of Pediatrics St Louis University
St Louis, Missouri, United States, 63104
2
Service Universitaire de Néonatologie CHR de la Citadelle
Liège, Belgium, 4000
3
Service de néonatologie Hôpital de la Croix Rousse
Lyon, France, 69317
4
Department of Child Health Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP