Clinical Experience With Numeta in Preterm Infants (Numeta)

September 25, 2017 updated by: Nadja Haiden,MD, Medical University of Vienna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 3 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

preterm infants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Numeta
parenteral receipt prescribed with Numeta
Other: Numeta
parenteral receipt prescribed with Numeta
Other: Individual
parenteral receipt prescribed individually
Individual
individually prescribed parenteral receipt
Other: Numeta
parenteral receipt prescribed with Numeta
Other: Individual
parenteral receipt prescribed individually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
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
6 weeks
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
6 weeks
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
6 weeks
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 weeks
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
6 weeks
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
6 weeks
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
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Nadja Haiden, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUV-Numeta

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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