Status:
UNKNOWN
Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis
Lead Sponsor:
Heinz Italia SpA
Conditions:
Neonatal Sepsis
Eligibility:
All Genders
Up to 72 years
Phase:
NA
Brief Summary
This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group. The aim of the study was to evaluate the hypothesis that an immunonutritional stra...
Detailed Description
15-20% of infant born weighing less than 1500 grams develop late-onset-sepsis. The prevention of sepsis is based on hygiene measures, on the prudent use of invasive procedures, on drug management and ...
Eligibility Criteria
Inclusion
- Newborns weighing less than 1500 grams
- Gestational age \<32 weeks
- Artificial feeding or Human milk not available \< 30%
Exclusion
- Voluntary interruption;
- Suspension decided by PI or PDF
- Adverse events
- Gastrointestinal disease that prevent oral feeding
- Congenital or maternal infections
- Immunodeficiencies
- Malformations
- Syndromes
- Genetic or metabolic diseases.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
876 Patients enrolled
Trial Details
Trial ID
NCT04742582
Start Date
March 1 2021
End Date
February 1 2024
Last Update
June 2 2022
Active Locations (1)
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1
Unità di Neonatologia e Terapia Intensiva Neonatale, Clinica Mangiagalli
Milan, Italy, 20122