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Personalized vs Standardized PN for Preterm Infants >1250g

NCT03693287 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-03-23

No results posted yet for this study

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.

Conditions

  • Infant,Premature
  • Parenteral Nutrition
  • Growth

Interventions

DRUG

Standardized-parenteral nutrition (S-PN)

NUMETA G13%E 300 mL is a triple-chamber (lipid emulsion, amino acids solution with electrolytes, and glucose solution), ready-to-use parenteral nutrition product available to treat preterm infants (less than 37 weeks gestational age).

DRUG

Personalized-parenteral nutrition (P-PN)

Intravenous glucose will be "dextrose 50%", amino acids (AA) will be "Primene®" and lipids (FAT) will be "Clinoleic®". Parenteral nutrition bags will be prepared by the hospital pharmacy according to the prescription of the attending neonatologist.

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • Ospedali Riuniti Ancona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
189 Days
Max Age
258 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-04
Primary Completion
2023-08-31
Completion
2024-10-31

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693287 on ClinicalTrials.gov