Is antenatal prednisone exposure associated with chronically elevated cortisol levels in children?
- Conditions
- autoimmune disorders1000135310028920
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
To be eligible for this trial, children in the study arm must meet all of the following criteria:
- Children between 5-17 years born to women with an autoimmune disorder, primarily RA, and prednisone use with a dose * 5mg/day during at least two trimesters of their pregnancy
- Parents of the child are able and willing to give written informed consent and comply with
the requirements of the study protocol;To be eligible for this trial, children in the control arm must meet all of the following criteria:
- Children between 5-17 years born to women with an autoimmune disorder, primarily RA, without prednisone use during their pregnancy
- Parents of the child are able and willing to give written informed consent and comply with
the requirements of the study protocol
1) monozygotic twins
2) non-Caucasian children
3) children with congenital abnormalities
4) parental refusal to participate
5) children with hair shorter than 2cm
6) children with chronic illness
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>I) hair cortisol measurements<br /><br>- proximal 3 cm hair (with about 100 hairs) will be cut from the back of the<br /><br>scalp of the child<br /><br><br /><br>II) anthropometric data of the child<br /><br>- bloodpressure: 3 times measured on one day<br /><br>- height and weight<br /><br>- waist and hip circumference<br /><br>- fat percentage using a skin fold measured by Holtain caliper<br /><br><br /><br>III) questionnair:<br /><br>- information on hair, hair products and medication use of the child<br /><br><br /><br>IV) since the child*s body composition is related to that of its parents, data<br /><br>on height and weight of both parents will be obtained</p><br>
- Secondary Outcome Measures
Name Time Method <p>I) DNA analysis in buccal epithelial cells obtained by a mouth swab<br /><br></p><br>