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Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Summary
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers. Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.
Key Details
Gender
All
Age Range
Any - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2014-01-01
Completion Date
2027-12-31
Last Updated
2023-08-14
Healthy Volunteers
No
Interventions
Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Locations (1)
Neonataology Service, BCNatal Hospital Clinic Seu Maternitat
Barcelona, Spain