Body composition and neurodevelopment in preterm infants
Recruiting
- Conditions
- groei en lichaamssamenstellingbrain developmentbody composition1004225810028920
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Premature infants born before 30 weeks of gestation and admitted to the
neonatal intensive care unit, Erasmus MC-Sophia Children's Hospital, Rotterdam,
the Netherlands
Exclusion Criteria
Severe congenital en/of chromosomal abnormalities
Asfyxia (defined by cord blood or (if absent) first postnatal pH < 7.0)
Intraventricular hemorrhage grade III/IV
Posthemorrhagic ventricular dilation requiring lumbal punctures
Congenital (TORCHES) infection (Toxoplasmosis, Rubella, CMV, Herpes, Hepatitis,
Coxsackie, Syphilis, Varicella Zoster, HIV, Parvo B19)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Body composition measured by PEAPOD/BODPOD, defined by fat mass (FM, gram) and<br /><br>fat free mass (FFM, gram) using the BOD POD or DXA<br /><br><br /><br>Neurodevelopment measured using Bayley Scales of Infant and Toddler<br /><br>Development, third edition (Bayley-III-NL), at 2 years corrected age and<br /><br>Wechsler Preschool and Primary Scale of Intelligence, third edition<br /><br>(WPPSI-III-NL), general intelligence assessment at 5.5 years corrected age and<br /><br>Wechsler Intelligence Scale For Children (WISC-V-NL), general intelligence<br /><br>assessment at 8 years corrected age. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Growth pattern<br /><br>- Nutritional intake (enteral and parenteral)<br /><br>- CUS measurements<br /><br>- Neurodevelopment at 2 years corrected age (Bayley-III motor score, Lexi-list<br /><br>and CBCL 1,5-5), 3 years corrected age (BRIEF-P and CBCL 1,5-5), 5,5 years<br /><br>corrected age (M-ABC-2, BRIEF-P and CBCL 1,5-5) and 8 years corrected age<br /><br>(M-ABC-2, BRIEF-2 and CBCL 6-18, TRF 6-18, OBVL).<br /><br>- Processing of visual stimuli (Eyetracker)<br /><br>- Sleep and circadian rhythm<br /><br>- Dental health status at 5.5 and 8 years corrected age<br /><br>- Bone mineral density at 3, 5,5 and 8 years corrected age<br /><br>- Parents* and patient reported quality of life (PedsQL and PROMIS 7+2) of<br /><br>preterm born children at 8 years corrected age.<br /><br>- Parents* needs in the neonatal follow-up program (qualitative research).<br /><br></p><br>
Related Research Topics
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What molecular pathways link body composition to neurodevelopmental outcomes in preterm infants?
How does early body composition assessment compare to standard-of-care monitoring for predicting brain development in preterm neonates?
Which biomarkers correlate with neurodevelopmental trajectories in preterm infants with abnormal adipose tissue distribution?
What adverse events are associated with longitudinal body composition monitoring in preterm infants using non-invasive techniques?
Are combination therapies involving nutritional interventions and neuroprotective strategies effective for optimizing growth and brain development in preterm infants?