Clinical Tolerance of Numeta 13% (BAXTERULG2)
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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. |
- 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
- 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 ]
- 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 |
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.
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| 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 | |
| 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 Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013