MedTrace Logo

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

NCT05945017 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2023-08-14

No results posted yet for this study

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

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Benjamin James Baucells, MD · Neonataology Service, BCNatal Hospital Clínic

  • Giorgia Sebastiani · Neonatology Service, BCNatal Hospital Clínic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2019-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945017 on ClinicalTrials.gov