Neonatal reference values for thyroid hormones and validation of dried blood spot measurements in the neonatal period

Neonatal reference values for thyroid hormones and validation of dried blood spot measurements in the neonatal period - Neonatal thyroid hormone reference intervals

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46842

Enrollment

120

Registered

2018-07-17

Start date

2016-08-30

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Congenital hypothyroidism / Inadequate thyroid hormone production from birth

Interventions

Congenital hypothyroidism

First recall

Neonatal screening

Reference values

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria: • Known maternal thyroid disease • Daily maternal use of medication influencing neonatal thyroid function • Prematurity (gestational age

Design outcomes

Primary

Measure	Time frame
1. Concentrations of plasma thyroid hormones in healthy neonates at the time of the neonatal screening (day 3-7 of life). 2. Concentrations of plasma thyroid hormones in healthy neonates around the 14th day of life. 3. Concentrations of thyroid hormones measured in dried blood spot at the time of the neonatal screening.	—

Secondary

Measure	Time frame
4. Preference of parents for a venous blood collection or heel stick in the neonatal screening.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)