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Completed

NCT Number: NCT01981057

Clinical Experience With Numeta in Preterm Infants

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

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Key information

Conditions

Premature Infants Female Urogenital Diseases and Pregnancy Complications Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

1 hour–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Numeta

Other

parenteral receipt prescribed with Numeta

Individual

Other

parenteral receipt prescribed individually

Primary outcomes

  1. Protein

    Time frame: 6 weeks

    Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations.

Secondary outcomes

  1. Energy

    Time frame: 6 weeks

    Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  2. Carbohydrates

    Time frame: 6 weeks

    Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  3. Fat

    Time frame: 6 weeks

    Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  4. Sodium

    Time frame: 6 weeks

    Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  5. Potassium

    Time frame: 6 weeks

    Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  6. Calcium

    Time frame: 6 weeks

    Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  7. Magnesium

    Time frame: 6 weeks

    Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  8. Phosphorous

    Time frame: 6 weeks

    Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

  9. Osmolarity

    Time frame: 6 weeks

    Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or "vice versa". This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Clinical Experience With Numeta- Impact on Intake of Nutrients and Costs

Acronym: Numeta

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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