Premature Infants
Conditions
Keywords
parenteral nutrition, Numeta, prescription software Cato Pan
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
Interventions
OTHERNumeta
parenteral receipt prescribed with Numeta
OTHERIndividual
parenteral receipt prescribed individually
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Numeta parenteral receipt prescribed with Numeta
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually | 50 |
| Individual individually prescribed parenteral receipt
Numeta: parenteral receipt prescribed with Numeta
Individual: parenteral receipt prescribed individually | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Numeta | Individual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 233 days of gestation | 233 days of gestation | 233 days of gestation |
| Region of Enrollment Austria | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Numeta | Protein | 3.1 g/kg/d |
| Individual | Protein | 3.6 g/kg/d |
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks
Secondary
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
Time frame: 6 weeks