Status:
UNKNOWN
Clinical Trial for Valuation of the Effectiveness of Lactoferrine in the Prevention of Sepsis in New Premature Born. Bimonitorization of the Antinflammatory Mechanisms, Antioxidants and the Intestinal Microbiote.
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Conditions:
SEPSIS SYNDROME
Eligibility:
All Genders
Up to 32 years
Phase:
NA
Brief Summary
To evaluate the efficacy of enteral administration of bovine lactoferrin (bLf) in the reduction of probable late sepsis or microbiologically proven in preterm infants with birth weight ≤ 1500 gr and /...
Detailed Description
To date there are no published clinical data that jointly assess the impact of direct Lf supplementation on oxidative status, on biomarkers of systemic inflammation and on the microbiota of premature ...
Eligibility Criteria
Inclusion
- Both groups will include male or female children born preterm with birth weight ≤ 1500 g and / or EG ≤ 32 weeks. All tutors of patients, must sign the informed consent.
Exclusion
- In both groups those subjects who do not meet the age and weight established at birth, have\> 72 hours of life at the time of inclusion, who do not sign informed consent or who have the following morbidities will be discarded: 1) Early sepsis or vertical; 2) Gastrointestinal congenital anomalies; 3) Chromosomopathies; 4) Congenital anomalies and / or genetic diseases without survival expectations; 5) Severe perinatal hypoxia.
Key Trial Info
Start Date :
May 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03472170
Start Date
May 4 2017
End Date
March 1 2020
Last Update
November 14 2019
Active Locations (1)
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1
Hosìtal Universitario Reina Sofia
Córdoba, Spain, 14004