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ACTIVE NOT RECRUITING
NCT05945017
NA

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

Sponsor: Fundacion Clinic per a la Recerca Biomédica

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748

Locations (1)

Neonataology Service, BCNatal Hospital Clinic Seu Maternitat

Barcelona, Spain