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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006440-55-DE
Enrollment
Unknown
Registered
2007-04-23
Start date
2007-08-27
Completion date
Unknown
Last updated
2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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-

Sponsors

University Childrin's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Inborn error of metabolism which requires a reduction of amino acid intake

Design outcomes

Primary

MeasureTime frame
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.. Examination of growth (weight gain, linear and head growth) until hospital discharge.;Primary end point(s): base excess due to hyperammonemia

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026