Intake and growth in late preterms
Completed
- Conditions
- neonatologie, groei, voeding en ontwikkelingnutritional management and preterms
- Registration Number
- NL-OMON44660
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
- born between 32 and 35 6/7 weeks of gestational age
- will not be transferred to an other hospital before discharge
- will visit the Outpatient Clinic of the MCA after discharge
Exclusion Criteria
- congenital abnormalities of the gastro-intestinal tract
- cardiac abnormalities
- metabolic or chromosomal/syndromal diseases
- infants that develop necrotising enterocolitis stage IIb or III (NEC)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint:<br /><br>To prospectively obtain the (parenteral/enteral) intake of protein, fat,<br /><br>carbohydrates and calories in 200 moderately preterm infants (32-36 weeks) and<br /><br>obtain prospectively growth data in the first 2 years of life. The main study<br /><br>parameter is to correlate the intake data with the postnatal growth data at the<br /><br>age of 2 years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints:<br /><br>The intake and growth data will be compared with a Bayley Scales of Infant<br /><br>development (BSID-III) test at the age of 24 months to determine whether intake<br /><br>or growth in the first 2 years of life is a risk factor for an impaired motor<br /><br>or mental development. Thirdly, a body composition measurement at the age of 2<br /><br>years will be performed to determine whether intake and growth in the first 2<br /><br>years of life have an effect on body composition in moderately preterm infants.<br /><br>This could indicate whether these infants will be at risk for long term<br /><br>morbidities like the metabolic syndrome as described in extremely preterm<br /><br>infants. The goal is to obtain the Bayley scores of mental and motor<br /><br>development and the body composition of 100 moderately preterm infants. </p><br>