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Body composition and neurodevelopment in preterm infants

Body composition and neurodevelopment in preterm infants - BOND

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53045
Enrollment
150
Registered
2014-09-03
Start date
2014-09-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

groei en lichaamssamenstelling body composition brain development

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Severe congenital en/of chromosomal abnormalities Asfyxia (defined by cord blood or (if absent) first postnatal pH

Design outcomes

Primary

MeasureTime frame
Body composition measured by PEAPOD/BODPOD, defined by fat mass (FM, gram) and fat free mass (FFM, gram) using the BOD POD or DXA Neurodevelopment measured using Bayley Scales of Infant and Toddler Development, third edition (Bayley-III-NL), at 2 years corrected age and Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III-NL), general intelligence assessment at 5.5 years corrected age and Wechsler Intelligence Scale For Children (WISC-V-NL), general intelligence assessment at 8 years corrected age.

Secondary

MeasureTime frame
- Growth pattern - Nutritional intake (enteral and parenteral) - CUS measurements - Neurodevelopment at 2 years corrected age (Bayley-III motor score, Lexi-list and CBCL 1,5-5), 3 years corrected age (BRIEF-P and CBCL 1,5-5), 5,5 years corrected age (M-ABC-2, BRIEF-P and CBCL 1,5-5) and 8 years corrected age (M-ABC-2, BRIEF-2 and CBCL 6-18, TRF 6-18, OBVL). - Processing of visual stimuli (Eyetracker) - Sleep and circadian rhythm - Dental health status at 5.5 and 8 years corrected age - Bone mineral density at 3, 5,5 and 8 years corrected age - Parents* and patient reported quality of life (PedsQL and PROMIS 7+2) of preterm born children at 8 years corrected age. - Parents* needs in the neonatal follow-up program (qualitative research).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)