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Clinical Experience With Numeta in Preterm Infants

NCT ID: NCT01981057

Last Updated: 2017-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Premature Infants

Keywords

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parenteral nutrition Numeta prescription software Cato Pan

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Numeta

parenteral receipt prescribed with Numeta

Numeta

Intervention Type OTHER

parenteral receipt prescribed with Numeta

Individual

Intervention Type OTHER

parenteral receipt prescribed individually

Individual

individually prescribed parenteral receipt

Numeta

Intervention Type OTHER

parenteral receipt prescribed with Numeta

Individual

Intervention Type OTHER

parenteral receipt prescribed individually

Interventions

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Numeta

parenteral receipt prescribed with Numeta

Intervention Type OTHER

Individual

parenteral receipt prescribed individually

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Nadja Haiden,MD

Assoc.Prof.MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadja Haiden, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Kreissl A, Repa A, Binder C, Thanhaeuser M, Jilma B, Berger A, Haiden N. Clinical Experience With Numeta in Preterm Infants: Impact on Nutrient Intake and Costs. JPEN J Parenter Enteral Nutr. 2016 May;40(4):536-42. doi: 10.1177/0148607115569733. Epub 2015 Feb 5.

Reference Type DERIVED
PMID: 25655621 (View on PubMed)

Other Identifiers

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MUV-Numeta

Identifier Type: -

Identifier Source: org_study_id