The aim of this study is to determine whether children between 5-17 years born to women with an autoimmune disorder and prednisone use during pregnancy have chronically elevated cortisol levels compared to children born to women with an autoimmune…
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
I) hair cortisol measurements
- proximal 3 cm hair (with about 100 hairs) will be cut from the back of the
scalp of the child
II) anthropometric data of the child
- bloodpressure: 3 times measured on one day
- height and weight
- waist and hip circumference
- fat percentage using a skin fold measured by Holtain caliper
III) questionnair:
- information on hair, hair products and medication use of the child
IV) since the child*s body composition is related to that of its parents, data
on height and weight of both parents will be obtained
Secondary outcome
I) DNA analysis in buccal epithelial cells obtained by a mouth swab
Background summary
In 2002 the PARA-study (Pregnancy induced Amelioration of Rheumatoid Arthritis)
was started to prospectively study the influence rheumatoid artritis and
medication use on the pregnancy outcome.
Recently we have shown in this study group that the children born to women with
RA and prednisone use during pregnancy have higher daytime cortisol levels in
saliva at age 7 compared to children born to women without prednisone use. This
finding correlates with earlier animal studies. Chronically elevated cortisol
levels in childhood have been associated with hypertension, cardiovascular
disease, and non-insulin dependent diabetes mellitus (DM) in adulthood.
Cortisol in saliva is not suitable for long-term cortisol measurements due to
the circadian rhythm, pulsatile secretion, daily variation and reactivity to
acute (transient) stress. Hair cortisol seems to more adequately reflect the
long-term cortisol levels. The aim of current research proposal is to get more
insight into the lifelong consequences of antenatal prednisone exposure on the
long-term cortisol levels as reflected in the hair cortisol. Additionally, we
want to perform DNA analysis in buccal epithelial cells, obtained by mouth
swabs, to determine whether the observed findings are related to
DNA-polymorphisms or changes in DNA-methylation.
During pregnancy there are limited options for the treatment of autoimmune
disorders. Prednisone is a widespread used drug.
The result of this study will inform us about the safety of prednisone use
during pregnancy, especially the long-term effects on the offspring.
Study objective
The aim of this study is to determine whether children between 5-17 years born
to women with an autoimmune disorder and prednisone use during pregnancy have
chronically elevated cortisol levels compared to children born to women with an
autoimmune disorder without prednisone use. And whether this is associated with
physical signs of higher cortisol levels (body composition, blood pressure).
We will also determine whether the observed findings are related to
DNA-polymorphisms or changes in DNA-methylation.
The result of this study could change current treatment strategies of pregnant
women with an autoimmune disease to minimize potential life long risk of the
offspring.
Study design
case-control study
Study burden and risks
- the hair collection and mouth swab is non-invasive
- the burden is the time investment of one hour for the hair and buccal
epithelial cell collection, physical examination (for anthropometric data) and
questionnair
Wytemaweg 12
Rotterdam 3015 CN
NL
Wytemaweg 12
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49156.078.14 |