Clinical Tolerance of Numeta 13% (BAXTERULG2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital of Liege
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Jacques Rigo, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT01772927
First received: January 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention
Other Preterm Infants
Transitory Neonatal Electrolyte Disturbance
Disorder of Mineral Metabolism
Failure to Thrive
Dietary Supplement: Parenteral Nutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Parenteral Nutrition in Premature Infants Weighing Less Than 1500 g Using Numeta G13% From the First Day of Life. A Prospective, Open-labeled Study on Intakes and Nutritional Markers.

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Protein and energy intakes in the range of the recommendations [ Time Frame: First two weeks of life ] [ Designated as safety issue: No ]
    AA intake >2 g/kg*d at day 1 and >3.5 g/kg*d at day 7-15 Energy intake> 40 kcal/kg*d at day 1 and >110 kcal/kg*d at day 7-15


Secondary Outcome Measures:
  • Minimal electrolyte's and mineral's disturbances during the first 2 weeks of life [ Time Frame: During the firt two weeks of life ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • insulin days< 10% and hypertriglyceridemia > 300 mg<5% of the parenteral days [ Time Frame: during the first two weeks of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Very low birth weight infants,
Parenteral nutrition
Dietary Supplement: Parenteral Nutrition
Protein and energy intakes
Other Name: Numeta G13%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Being a non-comparative study of therapeutic use, the sample size determination is not inferred from statistical calculation. However, in order to collect a relevant number of parenteral days in a relevant population of preterm infants, a total of 30 preterm infants with a birth weight< 1500 g will be included in the study cohort.

Criteria

Inclusion Criteria:

  • All preterm infants< 1500 g requiring parenteral nutrition from the first day, will be include in the study on the base of consecutive admission rate. However, In order to be representative of the ELBW and VLBW population of NICU, inclusions will be limited to the first 15 VLBW infants of each categories, (<1000 g, 1000 to <1250 g and 1250 to <1500 g). An additional recruitment of 5 infants in each category groups will be necessary to obtain at least 10 infants receiving significant parenteral nutritional supply in the final analysis.

Exclusion Criteria:

  • preterm infants who died during the first days of life < 7 days, preterm infants receiving early oral nutrition with an intake >50% of the nutritional requirement between 5 to 7 days of life, preterm infants with any contraindication of conventional Parenteral Nutrition (inborn error of metabolism, severe multi-organ failure ) will be exclude from the per protocol analysis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772927

Locations
Belgium
Department of Neonatology University hospital of Liege Not yet recruiting
Liege, Belgium, 4000
Contact: Thibault Senterre, MD PhD    00 32 4 225 6322    thibault.senterre@chu.ulg.ac.be   
Contact: Masendu Kalenga, MD PhD    00 32 4 6546    Masendu.kalenga@chrcitadelle.be   
Sub-Investigator: Thibault Senterre, MD PhD         
Sponsors and Collaborators
University Hospital of Liege
Baxter Healthcare Corporation
Investigators
Principal Investigator: Jacques Rigo, MD, PhD University Hospital of Liege
  More Information

No publications provided

Responsible Party: Jacques Rigo, MD, PhD, Past professor of neonatology and Pediatric Nutrition, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT01772927     History of Changes
Other Study ID Numbers: ULGCHR-11012013-BAXTER, 2012-005537-36
Study First Received: January 17, 2013
Last Updated: January 17, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital of Liege:
parenteral nutrition
Very low birth weight infants
preterm infants
biochemical tolerance
nutritional intake

Additional relevant MeSH terms:
Failure to Thrive
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014