Clinical trial NCT05945017: Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Official title: Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant, Newborn, Diseases
Infant Development
Keywords: Probiotics
Bifidobacterium bifidum
Lactobacillus acidophilus
Neurodevelopment
Prematurity
Late-onset sepsis
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2023-07-14
Enrollment: 233
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential study with consecutive recruitment with a washout period of 12 months between groups
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Premature infants under 32 weeks gestational age and less than 1500g birthweight.
* Born at BCNatal Hospital Clínic between years 2014-2019.

Exclusion Criteria:

* All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded.
* Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

Primary outcomes:
measure: Degree of neurodevelopment at 24 months corrected age
timeFrame: 24 months
measure: Degree of neurodevelopment at 24 months corrected age
timeFrame: 24 months
measure: Degree of neurodevelopment at 24 months corrected age
timeFrame: 24 months
measure: Degree of neurodevelopment at 24 months corrected age
timeFrame: 24 months
measure: Degree of neurodevelopment at 6 years of age
timeFrame: 6 years
measure: Degree of neurodevelopment at 6 years of age
timeFrame: 6 years
measure: Degree of neurodevelopment at 6 years of age
timeFrame: 6 years
measure: Neuroplasticity biomarkers and intestinal permeability
timeFrame: 6 years
Secondary outcomes:
measure: Incidence of necrotising enterocolitis
timeFrame: 40 weeks
measure: Mortality
timeFrame: 40 weeks
measure: Incidence of late onset sepsis
timeFrame: 40 weeks
measure: Incidence of Intraventricular haemorrhage
timeFrame: 40 weeks
measure: Intensive care length of stay
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Neonataology Service, BCNatal Hospital Clinic Seu Maternitat
Study officials:
affiliation: Neonataology Service, BCNatal Hospital Clínic
name: Benjamin James Baucells, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatology Service, BCNatal Hospital Clínic
name: Giorgia Sebastiani
role: PRINCIPAL_INVESTIGATOR
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