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Is antenatal prednisone exposure associated with chronically elevated cortisol levels in children?

Is antenatal prednisone exposure associated with chronically elevated cortisol levels in children? - Hair cortisol and intrauterine prednisone exposure (HAIR)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44675
Enrollment
360
Registered
2014-10-08
Start date
2015-05-19
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune disorders

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
I) DNA analysis in buccal epithelial cells obtained by a mouth swab

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)