Clinical Experience With Numeta in Preterm Infants

NCT01981057 | Completed Results

• 1 other identifier: MUV-Numeta
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Premature Infants

Keywords

parenteral nutrition; Numeta; prescription software Cato Pan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Energy

  6 weeks

• Carbohydrates

  6 weeks

• Fat

  6 weeks

• Sodium

  6 weeks

• Potassium

  6 weeks

Study Arms (2)

Numeta

parenteral receipt prescribed with Numeta

Other: Numeta; Other: Individual

Individual

individually prescribed parenteral receipt

Other: Numeta; Other: Individual

Interventions

Numeta OTHER

parenteral receipt prescribed with Numeta

Individual; Numeta

Individual OTHER

parenteral receipt prescribed individually

Individual; Numeta

Eligibility Criteria

• Age: 1 Hour - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

preterm infants

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 25655621 DERIVED

MeSH Terms

Conditions

Premature Birth; Hyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nadja Haiden M.D.
• Organization: Medical University of Vienna

nadja.haiden@meduniwien.ac.at

+4314040032320

Study Officials

• Nadja Haiden, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.MD

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 26, 2017
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

AU (1)