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Clinical Experience With Numeta in Preterm Infants

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Medical University of Vienna

Status

Completed

Conditions

Premature Infants

Treatments

Other: Individual
Other: Numeta

Study type

Observational

Funder types

Other

Identifiers

NCT01981057
MUV-Numeta

Details and patient eligibility

About

The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions

Enrollment

50 patients

Sex

All

Ages

1 hour to 3 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • preterm infants <37 weeks gestational age
  • parenteral nutrition therapy

Exclusion criteria

  • hypersensitivity to egg, soy or peanut proteins or to any of the active substances
  • congenital abnormality of the amino acid metabolism
  • pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous
  • severe hyperglycemia
  • severe hyperlipidemia
  • severe disorders of lipid metabolism characterized by hypertriglyceridemia

Trial design

50 participants in 2 patient groups

Numeta
Description:
parenteral receipt prescribed with Numeta
Treatment:
Other: Numeta
Other: Individual
Individual
Description:
individually prescribed parenteral receipt
Treatment:
Other: Numeta
Other: Individual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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