UnknownNot Applicable

Clinical Tolerance of Numeta 13%

Belgium30 participantsStarted 2013-01

Plain-language 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

Who can participate

Age range1 Day – 30 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Protein and energy intakes in the range of the recommendations

Timeframe: First two weeks of life

Trial details

NCT IDNCT01772927

SponsorUniversity of Liege

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-05