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Body composition and neurodevelopment in preterm infants


- candidate number24677
- NTR NumberNTR5985
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2016
- Secondary IDsMEC-2014-379 
- Public TitleBody composition and neurodevelopment in preterm infants
- Scientific TitleBody composition and neurodevelopment in preterm infants
- ACRONYMBOND
- hypothesisEarly 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.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Neurodevelopmental outcome, Body composition
- Inclusion criteriaPreterm birth < 30 weeks of gestation
Admission to NICU within 48 hours after birth
Written informed consent
- Exclusion criteriaSevere 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 14-sep-2014
- planned closingdate
- Target number of participants150
- Interventionsnot applicable - observational trial
- Primary outcomeBody 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 outcomeBody 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
- TimepointsFollow-up at: term-equivalent age, 6 weeks, 6 months, 1 year and 2 years corrected age
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jorine A. Roelants
- CONTACT for SCIENTIFIC QUERIES Koen F.M. Joosten
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationsnot applicable
- Brief summaryThis 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
- Main changes (audit trail)
- RECORD21-jul-2016 - 11-sep-2016


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