utrition in relation to the endocrine regulation of preterm growth
- Conditions
- Preterm infantsInsulin-like growth factor IGrowthBody composition
- Registration Number
- NL-OMON27985
- Lead Sponsor
- VU University medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
In October 2016 the following changes were made:
- An additional reference group (n=100) of infants born between 32 and 42 weeks of gestation has been added for the analysis of endocrine parameters in cord blood;
In January 2017 the following changes were made:
- The intervention is stopped, because of insufficient number of formula-fed infants;
- The number of participants with a gestational age less than 32 weeks was reduced from 150 to 70.
1. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language.
2. Gestational age of 24 to 32 weeks.
3. Arterial catheter in situ.
In order to be eligible for cord blood analysis, a subject must meet all of the following criteria:
1. Gestational age of 24 to 42 weeks
2. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language.
A substantial congenital anomaly based on a chromosomal or syndromal disorder with a known effect on growth and body composition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Growth (height, weight, body proportions and growth pattern)<br /><br>2. Body composition<br /><br>3. Growth-related endocrine parameters
- Secondary Outcome Measures
Name Time Method 1. Psychomotor development<br /><br>2. Bone mineralization<br /><br>3. Lipid status<br /><br>4. Blood pressure