No registrations found.
ID
Source
Brief title
Health condition
preterm infants
body composition
neurodevelopmental outcome
nutrition
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body composition (percentage body fat) at 2 years corrected age
Neurodevelopmental outcome assessed by Bayley Scales of Infant and Toddler Development (mental and motor outcome measures) and eye-tracker at 2-years corrected age
Secondary outcome
Body composition at term-equivalent age, 6-weeks, 6-months corrected age.
Brain growth at 6-weeks corrected age.
Microbiome at 2-years corrected age.
Blood pressure at 2-years corrected age
Background summary
This is a single-center ongoing, longitudinal observational cohort study conducted in the Netherlands. The aim of the study is to assess the association between body composition, as proxy of metabolic health, and neurodevelopmental outcome in preterm infants born before 30 weeks of gestation. Preterm infants are followed-up until the corrected age of 2 years with regular visits including body composition measurements, other markers of metabolic health and assessment of brain growth and neurodevelopmental outcome
Study objective
Early nutrition in preterm infants is essential for growth and neurodevelopment. The last decades more aggressive nutrition has been implemented in clinical practice to ensure optimal growth and thereby optimal neurodevelopmental outcome, as previous cohort studies showed that catch-up growth is associated with an improved neurodevelopmental outcome. However, it has also been shown recently that catch-up growth is associated with obesity and non-communicable diseases already in childhood. No studies assessed the influence of early growth and early nutrition on body composition in preterm infants in relation to neurodevelopmental outcome. We hypothesize that catch-up growth in the early postnatal period results in increased neonatal and childhood fat mass, but not in improved neurodevelopmental outcome.
Study design
Follow-up at: term-equivalent age, 6 weeks, 6 months, 1 year and 2 years corrected age
Intervention
not applicable - observational trial
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 birth < 30 weeks of gestation
Admission to NICU within 48 hours after birth
Written informed consent
Exclusion criteria
Severe brain injury (IVH gr III/IV, post-hemorrhagic ventricular dilatation)
Perinatal asphyxia (pH < 7.00 and 5' min APGAR score <5)
Congenital TORCHES infection
Chromosomal abnormalities
Severe congenital anomalies
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 | NL5831 |
| NTR-old | NTR5985 |
| Other | : MEC-2014-379 |