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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
Neonataology Service, BCNatal Hospital Clinic Seu Maternitat
Barcelona, Spain
Degree of neurodevelopment at 24 months corrected age
Normal neurodevelopment will be considered when no muscle tone changes, no impaired fine or gross motor coordination, Bayley scale score between above 84, no behaviour disorders or visual disability.
Time frame: 24 months
Degree of neurodevelopment at 24 months corrected age
Mild impairment will be considered if any of the following: muscle tone changes, impaired fine or gross motor coordination, Bayley scale score between 71-84, moderate behaviour disorders or mild visual disability.
Time frame: 24 months
Degree of neurodevelopment at 24 months corrected age
Moderate impairment will be diagnosed when suffering from any of the following: spastic diplegia, hemiplegia, seizures (non-febrile), Bayley scores between 50-70, severe behaviour disorders, moderate visual disability or mild-moderate hypoacusis.
Time frame: 24 months
Degree of neurodevelopment at 24 months corrected age
Severe impairment will be attributed to subjects with any of the following: spastic quadriplegia, choreoathetosis, ataxia, Bayley score \<50, blindness or severe hypoacusis
Time frame: 24 months
Degree of neurodevelopment at 6 years of age
Wechsler Intelligence Scale for Children - Fifth edition. Ranges from below 69 to above 130. Scores from 90-109 indicate average, above it indicates above average and below, below average performance.
Time frame: 6 years
Degree of neurodevelopment at 6 years of age
Child behaviour checklist 6-18 years of age. 113 items about behaviour and social competence scored from 0 "absent" to 2 "occurs often"
Time frame: 6 years
Degree of neurodevelopment at 6 years of age
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2). Parent/teacher self reporting form.
Time frame: 6 years
Neuroplasticity biomarkers and intestinal permeability
NeuN, Doublecortin, GFAP, GDNF, Ki67, Nrf2, BDNF, NGF, neurotrophin-1 (NT-1), neurotrophin-3 (NT-3), neurotrophin-4 (NT-4), DYRK1A, HIF1α, S100B i GSK3B. IL1B, IL6, IL8, IL10, IL12, TNF- α
Time frame: 6 years
Incidence of necrotising enterocolitis
cases fulfilling the stage II or above of the modified Bell's Criteria
Time frame: 40 weeks
Mortality
Proportion of dead participants before discharge
Time frame: 40 weeks
Incidence of late onset sepsis
positive blood culture beyond 72 hours of life
Time frame: 40 weeks
Incidence of Intraventricular haemorrhage
Grade I-IV
Time frame: 40 weeks
Intensive care length of stay
Days of intensive care
Time frame: 40 weeks
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