None listed
Conditions
Brief 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.
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 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), docosahexaen
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).
Sponsors
University of Rome "La Sapienza"
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 20 Days
Healthy volunteers
No
Inclusion criteria
Newborns with birth weight <1500 g consecutively observed in Neonatal Intensive Care Unit
Exclusion criteria
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
Outcome results
None listed