Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

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.

NCT Number	NCT05945017
Lead Sponsor	Fundacion Clinic per a la Recerca Biomédica Collaborators: Hospital Clinic of Barcelona
Conditions	Infant, Newborn, Diseases, Infant Development
Enrollment	233 participants
Start Date	2014-01-01
Primary Completion	2019-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2023-08-14