Personalized vs Standardized PN for Preterm Infants >1250g
Infant,Premature, Parenteral Nutrition, Growth
About this trial
This is an interventional treatment trial for Infant,Premature focused on measuring Preterm, Infant, Parenteral Nutrition, Growth
Eligibility Criteria
Inclusion Criteria:
- Birth weight greater than 1250 grams,
- Gestational age between 189 and 258 days,
- In need of parenteral nutrition (PN),
- Signed informed consent by at least one parent or legal guardian.
Exclusion Criteria:
- Genetic, metabolic, or endocrine disorders diagnosed before/after enrolment
- Ceftriaxone or Coumarin therapy before/after enrolment,
- Calcium therapy before enrolment,
- Cholestasis or hepatic insufficiency before enrolment,
- Renal insufficiency before enrolment,
- Hyponatremia before enrolment,
- Hypertriglyceridemia before enrolment,
- Hypersensitivity reaction to components of parenteral nutrition before/after enrolment,
- Off-label use of drug therapy before/after enrolment,
- Absent informed consent.
Sites / Locations
- Ospedali Riuniti AnconaRecruiting
- Azienda Ospedaliera di PadovaRecruiting
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Personalized-Parenteral Nutrition (P-PN)
Standardized-Parenteral Nutrition (S-PN)
These patients will receive personalized parenteral nutrition (PN) as it is customary in the participating centers. Dosing range: glucose from 9 to 13 g/kg/d, AA from 2.0 to 3.0 g/kg/d, and FAT from 1.5 to 2.5 g/kg/d. Intravenous macronutrient intakes: PN day 1: 2.0 g/kg of AA, 1.6 g/kg of FAT and 9 g/kg of glucides. PN day 2: 2.5 g/kg of AA, 2.0 g/kg of FAT and 11 g/kg of glucides. PN day 3 and the days after: 3.0 g/kg of AA, 2.5 g/kg of FAT and 13 g/kg of glucides. Intravenous vitamins will be supplied according to local clinical practice. Variations in macronutrient intakes will be tolerated within ±20%. Nutritional goal: to ensure at least 2.5 g/kg/d of AA and 70 kcal/kg/d of no protein energy (NPE) from PN day 2.
These patients will receive standardized parenteral nutrition (PN) by using a triple chamber bag (Numeta G13%E®). Dosing range: 80-300 ml/d. Intravenous macronutrient intakes: 65 ml/kg at PN day 1, 80 ml/kg at PN day 2 and then 100 ml/kg from PN day 3. Nutritional goal: to ensure at least 2.5 g/kg/d of amino acids (AA) and 70 kcal/kg/d of no protein energy (NPE) from PN day 2.