Personalized vs Standardized PN for Preterm Infants >1250g

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Preterm infants (gestational age between 189 and 258 days) with a birth weight (BW) greater than 1250 grams will be randomized to personalized-parenteral nutrition (P-PN) or standardized-parenteral nutrition (S-PN). The aim of the study is to evaluate the effect of S-PN versus P-PN on growth of preterm infants with BW>1250 grams.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedali Riuniti Ancona
• Collaborators: Azienda Ospedaliera di Padova; Hospital Universitario La Paz

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.