No registrations found.
ID
Source
Brief title
Health condition
Body composition (fat mass, fat free mass)
Preterm infants
Brain
Growth
Lichaamssamenstelling (vetmassa, vetvrije massa)
Te vroeg geboren kinderen
Hersenen
Groei
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
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).
Statistical adjustment for lifestyle factors (questionnaires) and clinical parameters.
Background summary
This observational non-invasive study, conducted in a level IV NICU in Rotterdam, the Netherlands, aims to elucidate the association between body composition and neurodevelopmental outcome up to two years of age in preterm born infants.
Study objective
Preterm infants are at risk for neurodevelopmental impairment, but also for obesity and risk factors of cardiometabolic diseases. Nutrition in the early neonatal phase and altered early growth might be predisposing these risks. Early body composition is considered a proxy for long-term metabolic health and may be associated with brain development.
This study aims to elucidate the association between neurodevelopmental outcome and body composition. We hypothesize fat mass and fat free mass are associated with neurodevelopmental outcome at two years of age in preterm born infants.
Study design
NICU stay, term corrected age, 6 weeks, 6 months, 1 year and 2 year corrected age.
Intervention
not applicable
Jorine A. Roelants
Rotterdam 3015 CN
The Netherlands
+31 10 7036015
j.roelants@erasmusmc.nl
Jorine A. Roelants
Rotterdam 3015 CN
The Netherlands
+31 10 7036015
j.roelants@erasmusmc.nl
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)
3. Severe brain injury (defined by intraventricular hemorrhage grade III or IV, venous infarction or periventricular leucomalacia gr II or higher )
4. Post hemorrhagic ventricular dilatation requiring lumbal punctures
5. Congenital TORCHES infections
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5757 |
| NTR-old | NTR6024 |
| Other | : MEC-2014-379 |