Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 583
- Locations
- 2
- Primary Endpoint
- Incidence of necrotizing enterocolitis and all-cause mortality
Study Overview
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 (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 72 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Incidence of necrotizing enterocolitis and all-cause mortality
Time Frame: From birth until three months
The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.
Secondary Outcomes
- Incidence of Bronchopulmonary Dysplasia(From birth until three months)
- Incidence of patent ductus arteriosus(From birth until three months)
- Intestinal colonization by administered strains(From birth until three months)
- Days of Central Vascular Catheter(From birth until three months)
- Time to complete enteral nutrition(From birth until three months)
- Incidence of Late Onset Sepsis(From birth until three months)
- Length of hospital stay(From birth until three months)
- Weight change(From birth until three months)
Investigators
José Antonio Hurtado Suazo
Head of Neonatolgy Division. University Hospital Virgen de las Nieves
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental