Clinical Experience With Numeta in Preterm Infants

Study Overview
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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

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

Conditions
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Premature Infants

Intervention / Treatment
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* Other: Numeta
* Other: Individual


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Numeta<br>parenteral receipt prescribed with Numeta | Other: Numeta<br>* parenteral receipt prescribed with Numeta<br>Other: Individual<br>* parenteral receipt prescribed individually<br>|
| Individual<br>individually prescribed parenteral receipt | Other: Numeta<br>* parenteral receipt prescribed with Numeta<br>Other: Individual<br>* parenteral receipt prescribed individually<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Numeta, parenteral nutrition, prescription software Cato Pan