N/A
Completed N=100
Clinical Experience With Numeta in Preterm Infants
Source: ClinicalTrials.gov NCT01981057 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Protein — 3.1; 3.6 g/kg/d
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Protein |
3.1; 3.6 | — |
| SECONDARY Energy |
— | — |
| SECONDARY Carbohydrates |
— | — |
| SECONDARY Fat |
— | — |
| SECONDARY Sodium |
— | — |
| SECONDARY Potassium |
— | — |
| SECONDARY Calcium |
— | — |
| SECONDARY Magnesium |
— | — |
| SECONDARY Phosphorous |
— | — |
| SECONDARY Osmolarity |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01981057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.