Status:
COMPLETED
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
Lead Sponsor:
José Antonio Hurtado Suazo
Collaborating Sponsors:
University Hospital Virgen de las Nieves
Hospital Regional de Malaga
Conditions:
Premature Infants
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 72 years
Phase:
NA
Brief Summary
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis ...
Eligibility Criteria
Inclusion
- Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
- Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.
Exclusion
- Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
- Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
- Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
Key Trial Info
Start Date :
January 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT06501404
Start Date
January 10 2015
End Date
March 20 2020
Last Update
July 15 2024
Active Locations (1)
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1
Hospital Virgen de las Nieves
Granada, Spain, 18012