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.

Background information

The multichamber bag parenteral solution specially designed for preterm infant has been developed to provide adequate and appropriate mixture of macronutrients (amino acids, carbohydrates, lipids) and micronutrients (electrolytes, vitamins, trace-elements) through either peripheral or central veins in the range of the more recent nutritional recommendations for ELBW, VLBW and LBW infants requiring total or partial parenteral nutrition (Tsang & al 2005, Espghan-ESPEN Commentary 2005). The multichamber bag parenteral solution for preterm infants NumetaG13% has been evaluated in a phase III study entitled: "Safety use of a triple chamber bag formula, administered IV during 5 to 10 consecutive days, in preterm infants requiring parenteral nutrition." EudraCT Number: 2007-001378-97; PPM Number: 36830247 It was a prospective, multicentre, non-comparative phase III study limited to 5 to 10 days of parenteral nutrition. Preterm infants can be include without any restriction of postnatal age and according to the need of informed parental consent, only 30 % of the patient was included during the first 3 days of life. Weight gain and nutritional intakes from the multichamber bag parenteral solution, from additional parenteral and oral supplies were collected daily during the study. Biochemical parameters recorded during the study were limited to BUN, glycemia, triglyceridemia, natremia, kaliemia, calcemia, phosphatemia and plasma bicarbonate concentration collected at inclusion, and at 5 & 10 days of parenteral nutrition. Performance safety was assessed through the collection of vital signs and adverse events whereas, information on handling and administration of the Ped3CB was evaluated using a visual scale parameters.

Results of the study were summarized in a manuscript recently published in JPGN 2012 referred as. J. Rigo, ML. Marlowe, D. Bonnot, Th. Senterre, A. Lapillonne, E. Kermorvant-Duchemin, JM. Hascoet, R. Desandes, G. Malfilatre, P. Pladys, A. Beuchee, Virginie Colomb. Benefits of a New Pediatric Triple-Chamber Bag for Parenteral Nutrition in Preterm Infants. JPGN2012;54: 210-217

Numeta 13% has been registered in 18 countries in Europe via a decentralized procedure that ended 15th December 2010. In the NICU of the University of Liege, we decided to use Numeta 13% as our standard of parenteral solution for preterm infants from the first day of life and therefore to perform a quality control evaluation of this balanced parenteral solution from the first day of life in preterm infants with a birth weight <1500 g. collecting nutritional intakes from the bags, additional intakes as well as blood and urine biochemical markers currently evaluated in the NICU.

In this context, we recently reported that using a ready to use binary parenteral solution compounded in the pharmacy hospital it is possible to provide nutritional intakes in the range of the recommendations (Tsang 2005, ESPGHAN-ESPEN 2005), to abolish the cumulative nutritional deficit frequently observed in those preterm infants and to limit the postnatal growth restriction a preterm infants with a birth weight < 1250 g. (Senterre Th and Rigo J JPGN 2011, Acta Paediatrica 2012). In that study, we suggested that the use from birth of a RTU parenteral solution containing electrolytes, minerals and a high protein (AA):energy ratio improves clinical tolerance and reduces metabolic disturbances during the first week of life in this group of preterm infants (Senterre Th and Rigo J Manuscript in preparation)