The effect of an isocaloric, protein- and mineral-enriched ('postdischarge') formula on growth, body composition and bone mineralization of late preterm infants.;Follow-up: The effect of an isocaloric, protein- and mineral-enriched (*postdischarge*) formula on growth, body composition and neurocognitive development of late preterm infants at the corrected age of 2 years.
Completed
- Conditions
- (inhaal) groei, hypertensie, cognitieve/motorische/taal-ontwikkeling(catch up) growthmetabolic syndrome10013296
- Registration Number
- NL-OMON55631
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Birth at gestational age between 32 0/7 and 35 6/7 weeks., Follow-up:
participants of the LEGO-study
Exclusion Criteria
- gastro-intestinal surgery and disease known to influence growth (i.e. cystic
fibrosis and severe gastro-oesophageal reflux)
- known presence of growth hormone, IGF-1 or other pituitary hormone
deficiencies
- concurrent therapies with substances known or suspected to be associated with
alteration of growth (i.e. oral steroids)
- cardiac, renal, pulmonary and liver disease
- chromosomal and/or genetic syndromes
- known skeletal disease
- severe illness in general
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective: to compare growth and body composition between late preterm<br /><br>infants at 6 months corrected age, fed either isocaloric, protein- en<br /><br>mineral-enriched postdischarge formula or standard term formula between term<br /><br>age and 6 months corrected age.<br /><br><br /><br>- growth; weight, length and headcircumference<br /><br>- body composition; fat mass and fat free mass<br /><br><br /><br>Follow-up:<br /><br>- growth: Weight, length, head circumference, waist circumference,<br /><br>- body composition: fat mass and fat free mass</p><br>
- Secondary Outcome Measures
Name Time Method