Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 233
- Locations
- 2
- Primary Endpoint
- Neuroplasticity biomarkers and intestinal permeability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 32 Weeks (Child)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Neuroplasticity biomarkers and intestinal permeability
Time Frame: 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
Degree of neurodevelopment at 6 years of age
Time Frame: 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.
Degree of neurodevelopment at 24 months corrected age
Time Frame: 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.
Secondary Outcomes
- Incidence of necrotising enterocolitis(40 weeks)
- Incidence of late onset sepsis(40 weeks)
- Incidence of Intraventricular haemorrhage(40 weeks)
- Mortality(40 weeks)
- Intensive care length of stay(40 weeks)