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BOND study

Body composition and neurodevelopment in preterm infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24016
Enrollment
150
Registered
2016-08-02
Start date
2014-09-14
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Body composition (fat mass, fat free mass) Preterm infants Brain Growth Lichaamssamenstelling (vetmassa, vetvrije massa) Te vroeg geboren kinderen Hersenen Groei

Interventions

None listed

Sponsors

Erasmus MC - Sophia Children's hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm 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 criteria

Exclusion criteria: 1. Severe congenital and chromosomal anomalies 2. Perinatal asphyxia (defined as 5’min 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

Design outcomes

Secondary

MeasureTime frame
Body 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.

Primary

MeasureTime frame
Body 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.

Contacts

Public ContactJorine A. Roelants

Wytemaweg 80

j.roelants@erasmusmc.nl+31 10 7036015

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)