NCT05945017

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Newborn, Diseases
• Infant Development

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-12-31
• Completion: 2027-12-31
• First posted: 2023-07-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: Spain