brain development in preterm infants brain maturation in preterm infants
Conditions
Interventions
The intervention comprises a nutritional product that consists of two
components (part A and part B).
Test product group will receive:
- Part A: one daily dose of Bifidobacterium breve M-16V (3 x 1
1.5 x 109 cfu per day for preterm
infants with birth weight
Sponsors
Nutricia
Eligibility
Inclusion criteria
Inclusion criteria: - Gestational age of 24+0 to
Exclusion criteria
Exclusion criteria: - Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation - Presence of a congenital central nervous system infection - Presence of any gastrointestinal malformation - No realistic prospect of survival - Concomitant participation in other intervention studies (for example, but not exclusively, those studies involving investigational or marketed nutritional or pharmaceutical products) that could impact on the main outcome parameters and/or subject safety - Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions - Admission from an extra regional hospital, unless that hospital is a study site - Currrent use of gastric inhibitors: H2-receptor antagonists (including ranitidine) or proton pump inhibitors (including omeprazole)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the intervention period (from randomisation until and including TEA): Tract-Based Spatial Statistics analysis using the diffusion weighted imaging to investigate the difference in fractional anisotropy at TEA between the test group and control group | — |
Secondary
| Measure | Time frame |
|---|---|
| During the intervention period (from randomisation until and including TEA): - White matter injury score assessed according to Kidokoro et al. on T2 and T1 weighted MR images measured at TEA - Brain tissue volumes (cerebellar, cortical grey matter, unmyelinated white matter, deep nuclear grey matter and ventricular volumes, and extracerebral cerebrospinal fluid) and cortical morphology (sulcation index, cortical surface area, and cortical thickness) assessed on T2 and T1 weighted MR images measured at TEA - Occurrence of serious neonatal infections (defined as culture proven infection with clinical symptoms of an infection; clinically significant necrotising enterocolitis (defined as Bell*s stage two or higher); and/or meningitis with or without positive culture; or clinical respiratory infection >= 4 white blood cells per field associated with a specific pathogen in the tracheal aspirates; according to the categories proposed by Stoll et al.) until TEA - Serum concentrations of specific circulating inflammatory markers such as IL-6, IL-10, TNF-a and IL-8/CXCL8, measured at fixed time points until TEA, optional, and on the condition that blood is sampled at that time-point for routine clinical purposes. During the follow-up period (after TEA until 24 months corrected age): - Bayley Scales of Infant and Toddler Development-Third Edition scores on three subscales (cognitive, fine and gross motor) at 24 months corrected age | — |
Countries
Netherlands
Outcome results
None listed