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Clinical Tolerance of Numeta 13%

NCT01772927 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2013-01-21

No results posted yet for this study

Summary

Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra indicated. The product has been registered in 18 countries in Europe via a decentralized procedure that ended 15th December 2010.

The present study want to evaluate the use of Numeta 13% as standard medical prescription in the NICU of the university of Liege. It is a prospective, monocentric, non-interventional, non comparative, open-labeled data collection of record keeping, nutritional intakes from the bags, additional intakes as well as blood and urine biochemical markers currently evaluated in the NICU.

The data will be collected only in VLBWI \< 1500 g receiving Numeta G13% from day of birth (day 1) until parenteral nutrition (PN) decreases below 20% of the targeted intakes 2 days in a row as a quality control of the new solution in clinical practice.

Indication for PN and daily prescription will follow the protocol in use in the NICU on behalf of the investigators

Conditions

  • Other Preterm Infants
  • Transitory Neonatal Electrolyte Disturbance
  • Disorder of Mineral Metabolism
  • Failure to Thrive

Interventions

DIETARY_SUPPLEMENT

Parenteral Nutrition

Protein and energy intakes

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • University of Liege

    lead OTHER

Principal Investigators

  • Jacques Rigo, MD, PhD · University of Liege

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772927 on ClinicalTrials.gov