Clinical Experience With Numeta in Preterm Infants

Completed

• Conditions: Premature Infants
• Interventions: Other: Numeta; Other: Individual

• Registration Number: NCT01981057
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-11
• Status Verified: 2014-05
• Results First Submitted: 2014-05-10
• Results First Submitted QC: 2014-05-10
• Results First Posted: 2014-06-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individual	Numeta	individually prescribed parenteral receipt
Numeta	Numeta	parenteral receipt prescribed with Numeta
Numeta	Individual	parenteral receipt prescribed with Numeta
Individual	Individual	individually prescribed parenteral receipt

Primary Outcome Measures

Name	Time	Method
Protein	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 Outcome Measures

Name	Time	Method
Potassium	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
Magnesium	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
Fat	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
Phosphorous	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
Energy	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
Sodium	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
Osmolarity	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
Carbohydrates	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
Calcium	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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria