Effect on metabolic acidosis due to hyperammonemia of high versus low intake of amino acid in VLBW infants.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: Amninopäd® 10% Pharmaceutical Form: Intravenous infusion Other descriptive name: aminoacidmix Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 100 g/l‐ CONDITION: At birth, a VLBW infant is abruptly disconnected from the ideal source of parenteral nutrition ‐ 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: 9.1 Level: LLT Classification code 10063258 Term: Amino acid level PRIMARY OUTCOME: 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. Primary end point(s): base excess due to hyperammonemia 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..; Examination of growth (weight gain, linear and head growth) until hospital discharge. 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
Epistemonikos ID: be972e0a4419f559df686a1459521cc014f88b71
First added on: Aug 21, 2024