Effect on metabolic acidosis due to hyperammonemia of high versus low intake of amino acid in VLBW infants.
Active, not recruiting
- Conditions
- At birth, a VLBW infant is abruptly disconnected from the ideal source of parenteralnutrition - the placenta. If the goal of post-natal nutrition in the VLBW infant is to mimic in utero nutrition. The VLBW infant should be immediately placed on balanced parenteral nutrition. In current praxis parenteral nutrition used to be delayed for several days.MedDRA version: 9.1Level: LLTClassification code 10063258Term: Amino acid level
- Registration Number
- EUCTR2006-006440-55-DE
- Lead Sponsor
- niversity Childrin's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Preterm infant with a birth weight below 2000g
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Inborn error of metabolism which requires a reduction of amino acid intake
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Incidence of metabolic acidosis due to hyperamonemia with intake of 1.5 g/kg/d and increase to 3,5 g/kg/d amino acid from day 1 to day 5 of life in comparison to 3.5 g/kg/d amino acid at day 1 of life.;Secondary Objective: Comparison of extracellular water, total body water, energy expenditure, and protein and amino acid metabolism in the low and high amino acid group..<br>Examination of growth (weight gain, linear and head growth) until hospital discharge.;Primary end point(s): base excess due to hyperammonemia
- Secondary Outcome Measures
Name Time Method