BOND study
Recruiting
- Conditions
- Body composition (fat mass, fat free mass)Preterm infantsBrainGrowthLichaamssamenstelling (vetmassa, vetvrije massa)Te vroeg geboren kinderenHersenenGroei
- Registration Number
- NL-OMON24016
- Lead Sponsor
- Erasmus MC - Sophia Children's hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Preterm infants born before 30 weeks of gestation who are admitted to the NICU of the Erasmus MC within 48 hours after birth.
Written informed consent
Exclusion Criteria
1. Severe congenital and chromosomal anomalies
2. Perinatal asphyxia (defined as 5’min APGAR score below 5 and cord blood pH below 7.00)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body composition (percentage fat mass and fat-free mass) measured using air-displacement plethysmography and neurodevelopmental outcome assessed using Bayley Scales for Infant and Toddler Development, third edition and eye-tracking at 2 years corrected age.
- Secondary Outcome Measures
Name Time Method Body composition and brain growth assessed using cranial ultrasound or MRI and head circumference measurement at term equivalent age, 6 weeks and 6 months corrected age.<br>Potential factors influencing the interaction between the brain and the gut (gut-brain axis): nutrition (enteral and parenteral nutrition, breastfeeding), feces (microbiome), saliva (microbiome, cortisol, ghrelin and leptin), hair (cortisol).<br>Statistical adjustment for lifestyle factors (questionnaires) and clinical parameters.