Not Yet RecruitingPhase 3ACTRN12613000481774

Improvement of feeding tolerance by using a new formula in preterm neonates

Effects of a new hydrolyzed powdered formula on feeding tolerance in preterm neonates: a randomized placebo-controlled study


Sponsor

University of Rome "La Sapienza"

Enrollment

60 participants

Start Date

Jun 3, 2013

Study Type

Interventional

Conditions

Summary

The use of total parenteral nutrition is necessary to ensure the survival of very low birth weight (VLBW) infant in the first weeks of life, given (due) to the intestinal immaturity and to the lack of formulas able to adequately meet nutritional needs using the enteral route. The formulas for preterm infants, although characterized by a high intake of calories and protein, help meet the nutritional needs when administered at high volumes. However, delayed gastric emptying, typical of the first weeks of life of the preterm infant, limits the use of enteral nutrition as the sole source of energy and protein. On the other hand, prolonged use of parenteral nutrition is associated with an increased risk of infectious complications, metabolic and liver. Several studies show that the hydrolyzed formulas promote gastric emptying and provide better tolerance of enteral nutrition in adults and children. In the preterm infant, however, the use of this type of formulas is limited by poor nutritional value of the products currently available on the market. Therefore, the use of a hydrolyzate formula high in energy and protein, may improve tolerance while respecting nutritional needs.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 20 Dayss

Inclusion Criteria1

  • Newborns with birth weight <1500 g consecutively observed in Neonatal Intensive Care Unit

Exclusion Criteria1

  • Congenital or maternal infections, immunodeficiency, malformations, syndrome, genetic defects, evidence of infections and NEC before enrolment, critically ill condition (blood pH < 6.8, or hypoxia with persistent bradycardia for at least 1 hour), and hospitalization less than 2 weeks

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Interventions

Neonates in group 1 receive a new powdered hydrolyzed formula. Formula will be oral liquid administered, divided in 8 feed/day, by enteral route, for the first 4 weeks of life. Daily volume will be ad

Neonates in group 1 receive a new powdered hydrolyzed formula. Formula will be oral liquid administered, divided in 8 feed/day, by enteral route, for the first 4 weeks of life. Daily volume will be adjusted on body weight (150 ml/Kg/day). Macronutrients formula composition is reported below per 100 ml of product: whey protein 3.1 (g), lactose 4.6 (g), maltodextrins 4.2 (g), medium chain triglicerides 0.6 (g), linoleic acid 710 (mg), linolenic acid 80 (mg), arachidonic acid 18 (mg), docosahexaenoic acid 18 (mg).


Locations(1)

Rome, Italy

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ACTRN12613000481774