Infant Development, Infant, Newborn, Diseases
Conditions
Keywords
Probiotics, Bifidobacterium bifidum, Lactobacillus acidophilus, Neurodevelopment, Prematurity, Late-onset sepsis
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.
Interventions
DIETARY_SUPPLEMENTInfloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
Sponsors
Hospital Clinic of Barcelona
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential study with consecutive recruitment with a washout period of 12 months between groups
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of neurodevelopment at 24 months corrected age | 24 months | 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. |
| Degree of neurodevelopment at 6 years of age | 6 years | 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. |
| Neuroplasticity biomarkers and intestinal permeability | 6 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraventricular haemorrhage | 40 weeks | Grade I-IV |
| Incidence of necrotising enterocolitis | 40 weeks | cases fulfilling the stage II or above of the modified Bell's Criteria |
| Intensive care length of stay | 40 weeks | Days of intensive care |
| Mortality | 40 weeks | Proportion of dead participants before discharge |
| Incidence of late onset sepsis | 40 weeks | positive blood culture beyond 72 hours of life |
Countries
Spain
Outcome results
None listed