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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints revised (8)v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05945017
Lead Sponsor Fundacion Clinic per a la Recerca Biomédica
Collaborators: Hospital Clinic of Barcelona
Conditions
(from sponsor)		 Infant, Newborn, Diseases, Infant Development
Related terms Infant, Newborn, Diseases, Premature Birth
Enrollment 233 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov