Neonatal Sepsis Clinical Trial
Official title:
The Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis
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 strategy, based on use of Lactobacillus paracasei CBA L74-fermented formula, prevents or limits the development of late-onset-sepsis in preterm infants.
Status | Recruiting |
Enrollment | 876 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility | Inclusion Criteria: - Newborns weighing less than 1500 grams - Gestational age <32 weeks - Artificial feeding or Human milk not available < 30% Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Unita` di Neonatologia e Terapia Intensiva Neonatale, Clinica Mangiagalli | Milano |
Lead Sponsor | Collaborator |
---|---|
Heinz Italia SpA |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Monitoring of the number of confirmed episodes of late-onset-sepsis during hospitalization period and potential complications of the sepsis | Data collection concerning the appearance during hospitalization of episodes of sepsis from Gram positive, Gram negative bacteria and from fungi; the occurrence of comorbidities: necrotizing enterocolitis (NEC); bronchopulmonary dysplasia (BPD); intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), the mortality rate. | from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age) | |
Primary | Monitoring the number of days required to achieve complete enteral feeding, presence and duration of central vascular access | Data collection concerning the number of days required to achieve complete enteral feeding, presence and duration of central vascular access | from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age) | |
Primary | Monitoring the growth rate | Data collection concerning the growth rate (g/ kg/ day) | from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age) | |
Primary | Monitoring the length of hospital stay | Data collection concerning the lenght of the hospital stay | from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age) | |
Primary | Psychomotor development with the Griffiths III | Evaluation of the psychomotor development through development quotient using the Griffiths III. General quotient: A scale: learning basis; B scale: language and communication; C scale: eye-manual coordination; D scale: personal-social-emotional; E scale: gross-motor; average 100, DS 15. | at 180 days of life | |
Secondary | Fecal dosage of cathelicidines, alfa and beta defensins, sIgA | Dosage of biomarkers levels of innate and acquired immunity (cathelicidines, alfa and beta defensins, sIgA ) on fecal samples, using ELISA kits | at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age | |
Secondary | Microbiota | The V region of the 16S rRNA will be amplified using specific primers and the obtained amplicons will be used for sequencing library preparation, multiplexing and paired-end sequencing on the Illumina MiSeq platform. The alpha and beta diversity at the level of the phylum, genus and species among groups and their separation in a principal coordinate analysis will be evaluated. | at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age | |
Secondary | Cytokines production assessment on infants blood sample | Cytokines (IL-6, IL-12p40, TNF-a) production assessment on infants blood sample, using CBA (cytokine bead array) | at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age | |
Secondary | Cytokines production assessment on dendritic cells culture medium | Cytokines (IL-6, IL-12p40, TNF-a) production assessment on murine dendritic cells culture medium | at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age | |
Secondary | Cell surface activation markers (MHC and costimulatory molecules) | Determination of cell surface activation markers (MHC and costimulatory molecules) on dendritic cell after infant serum treatment and strong inflammatory stimulus (LPS or Salmonella typhimurium) | at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age |
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