Personalized Versus Standardized Parenteral Nutrition for Preterm Infants With a Birth Weight Greater Than 1250 Grams: a Multicenter Randomized Phase IV Clinical Trial
Who is this study for? Infants with Prematurity
What treatments are being studied? Parenteral Nutrition (S-PN)
Status: Unknown
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 8 months
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Ospedali Riuniti Ancona
RECRUITING
Ancona
Azienda Ospedaliera di Padova
RECRUITING
Padua
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Virgilio P Carnielli, MD, PhD
v.carnielli@univpm.it
+39 071 596 2045
Backup
Alessio Correani, MSc, PHD
alessio.correani@gmail.com
+39 071 596 2888
Time Frame
Start Date: 2021-07-04
Completion Date: 2024-10-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Personalized-Parenteral Nutrition (P-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.
Experimental: Standardized-Parenteral Nutrition (S-PN)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera di Padova, Hospital Universitario La Paz
Leads: Ospedali Riuniti Ancona