Clinical Tolerance of Numeta 13% (BAXTERULG2)
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|ClinicalTrials.gov Identifier: NCT01772927|
Recruitment Status : Unknown
Verified January 2013 by Jacques Rigo, University of Liege.
Recruitment status was: Not yet recruiting
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
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 or disease||Intervention/treatment|
|Other Preterm Infants Transitory Neonatal Electrolyte Disturbance Disorder of Mineral Metabolism Failure to Thrive||Dietary Supplement: Parenteral Nutrition|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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.|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||July 2013|
Very low birth weight infants,
Dietary Supplement: Parenteral Nutrition
Protein and energy intakes
Other Name: Numeta G13%
- Protein and energy intakes in the range of the recommendations [ Time Frame: First two weeks of life ]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
- Minimal electrolyte's and mineral's disturbances during the first 2 weeks of life [ Time Frame: During the firt two weeks of life ]
- insulin days< 10% and hypertriglyceridemia > 300 mg<5% of the parenteral days [ Time Frame: during the first two weeks of life ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772927
|Department of Neonatology University hospital of Liege|
|Liege, Belgium, 4000|
|Contact: Thibault Senterre, MD PhD 00 32 4 225 6322 email@example.com|
|Contact: Masendu Kalenga, MD PhD 00 32 4 6546 Masendu.firstname.lastname@example.org|
|Sub-Investigator: Thibault Senterre, MD PhD|
|Principal Investigator:||Jacques Rigo, MD, PhD||University of Liege|