Clinical trial NCT01208493: Dietary Protein in the Very-low-birth-weight Infant
Official title: Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prematurity
Keywords: prematurity
enteral feeding
proteins
formula
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-09-24
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: comparison of weight gain between both study groups as a measure of safety
timeFrame: 3 weeks
Secondary outcomes:
measure: comparison of feeding tolerance and metabolic status between study groups as a measure of safety
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Department of Pediatrics St Louis University
state: Missouri
city: Liège
country: Belgium
facility: Service Universitaire de Néonatologie CHR de la Citadelle
city: Lyon
country: France
facility: Service de néonatologie Hôpital de la Croix Rousse
city: Newcastle upon Tyne
country: United Kingdom
facility: Department of Child Health Royal Victoria Infirmary
Study officials:
affiliation: Department of Pediatrics St Louis University
name: Richard J Cooke, MD
role: PRINCIPAL_INVESTIGATOR
References: