Clinical Tolerance of Numeta 13%
BAXTERULG2
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.
2 other identifiers
observational
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJanuary 21, 2013
January 1, 2013
4 months
January 17, 2013
January 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protein and energy intakes in the range of the recommendations
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
First two weeks of life
Secondary Outcomes (1)
Minimal electrolyte's and mineral's disturbances during the first 2 weeks of life
During the firt two weeks of life
Other Outcomes (1)
insulin days< 10% and hypertriglyceridemia > 300 mg<5% of the parenteral days
during the first two weeks of life
Study Arms (1)
Very low birth weight infants,
Parenteral nutrition
Interventions
Protein and energy intakes
Eligibility Criteria
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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Liegelead
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
Department of Neonatology University hospital of Liege
Liège, Liege, 4000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Rigo, MD, PhD
University of Liege
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Past professor of neonatology and Pediatric Nutrition
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
January 21, 2013
Record last verified: 2013-01