Personalized versus standard intravenous nutrition for small preterm infants

Phase 1

• Conditions: Growth of preterm infants in case of reduced or absent enteral nutrition due to gastrointestinal intolerance or to an early or late disease.; MedDRA version: 21.1Level: PTClassification code 10051284Term: Parenteral nutritionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2018-004946-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Birth weight > 1250 grams,
- Gestational age at birth between 27.0 and 36.6 weeks,
- need of parenteral nutrition,
- informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- genetic, metabolic or endocrine disorders before/after enrolment;
- drug therapy with ceftriaxone or cumarina before/after enrolment;
- drug therapy with calcium before enrolment;
- cholestasis or hepatic insufficiency before enrolment;
- renal insufficiency before enrolment;
- hyponatremia before enrolment;
- hyperlipidemia/hypertriglyceridemia before enrolment;
- any hypersensitivity to the compounds of the study parenteral bags before/after enrolment;
- drug therapy with off-label drugs before/after enrolment;
- lacking informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified