eonatal reference values for thyroid hormones and validation of dried blood spot measurements in the neonatal period
Completed
- Conditions
- Congenital hypothyroidism / Inadequate thyroid hormone production from birth10021112
- Registration Number
- NL-OMON46842
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
• Age 3-7 days at neonatal screening.
• Neonatal screening needs to be performed in or around the AMC or OLVG
• Subject*s legal representatives are able and willing to give informed consent.
Exclusion Criteria
• Known maternal thyroid disease
• Daily maternal use of medication influencing neonatal thyroid function
• Prematurity (gestational age <37 weeks)
• Neonatal illness requiring hospitalization
• APGAR score less than 7 at 5 minutes
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Concentrations of plasma thyroid hormones in healthy neonates at the time of<br /><br>the neonatal screening (day 3-7 of life).<br /><br>2. Concentrations of plasma thyroid hormones in healthy neonates around the<br /><br>14th day of life.<br /><br>3. Concentrations of thyroid hormones measured in dried blood spot at the time<br /><br>of the neonatal screening.</p><br>
- Secondary Outcome Measures
Name Time Method <p>4. Preference of parents for a venous blood collection or heel stick in the<br /><br>neonatal screening.</p><br>