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BOND study


- candidate number24721
- NTR NumberNTR6024
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2016
- Secondary IDsMEC-2014-379 
- Public TitleBOND study
- Scientific TitleBody composition and neurodevelopment in preterm infants
- ACRONYMBOND study
- hypothesisPreterm 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.
- Healt Condition(s) or Problem(s) studiedBody composition, Brain, Preterm neonates, Growth
- Inclusion criteriaPreterm 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 criteria1. Severe congenital and chromosomal anomalies
2. Perinatal asphyxia (defined as 5ímin 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 14-sep-2014
- planned closingdate1-sep-2017
- Target number of participants150
- Interventionsnot applicable
- Primary outcomeBody 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 outcomeBody 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.
- TimepointsNICU stay, term corrected age, 6 weeks, 6 months, 1 year and 2 year 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)
Erasmus Medical Center, Sophia Children's Hospital
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD2-aug-2016 - 19-okt-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl