1. To establish reference intervals for thyroid hormones in plasma at the time of the neonatal screening (day 3-7 of life).2. To establish reference intervals for thyroid hormones in plasma around the 14th day of life.3. To compare the…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
4. Preference of parents for a venous blood collection or heel stick in the
neonatal screening.
Background summary
The Dutch neonatal screening program for congenital hypothyroidism is unique.
However, we still have little insight into the thyroid function during the
neonatal period. Directly following birth TSH concentrations increase following
the so-called 'postnatal TSH surge'. Consequently, FT4 concentrations also
increase dramatically in the first few days of life, after which both TSH and
FT4 gradually fall during the neonatal period. Due to the gradual decline of
hormones after the TSH-surge, thyroid hormone concentrations in the neonatal
period can't be compared to those in adulthood. A reliable reference interval
for these first weeks is still lacking. This makes it challenging to make a
correct diagnosis following an abnormal result in the neonatal screening.
Additionally, the Dutch screening uses a T4/TBG-ratio measured in a dried blood
spot as parameter for plasma FT4 concentrations. The use of this ratio in the
neonatal screening has never been validated. The association between the
T4/TBG-ratio in the dried blot spot and the serum FT4 concentration at the same
moment has never been investigated.
With more insight in the thyroid function during the neonatal period, and into
the relationship between the T4/TBG-ratio in the bloodspot and the serum FT4
concentration, we can improve the screening sensitivity, and detect and treat
neonates with abnormal screening results more efficiently.
Meanwhile, other European countries perform the neonatal screening using a
venous blood collection. Now the Dutch screening will be expanded with more
diseases, and it remains a challenge to take enough blood via a heelstick, a
switch from heelstick to a venous collection should be considered. If it
appears that parents prefer one method of collecting blood from their child,
this should be taken into consideration when deciding whether the Dutch
screening should switch to venous collection as well.
Study objective
1. To establish reference intervals for thyroid hormones in plasma at the time
of the neonatal screening (day 3-7 of life).
2. To establish reference intervals for thyroid hormones in plasma around the
14th day of life.
3. To compare the concentrations of thyroid hormones measured in plasma to
those measured in dried blood spot at the time of the neonatal screening.
4. To evaluate which method of blood collection parents prefer for the
neonatal screening.
Study design
A cross-sectional observational study.
Study burden and risks
Parents and/or legal representatives of subjects will be asked for an
additional venous blood collection from the subject during the routine
screening program heel puncture. Subjects will be invited to the hospital at 2
weeks after birth for a second venous blood collection. Risks involved with
blood collection are minimal, and may include pain, bleeding and bruising.
After the study is completed, parents will be asked to fill in a questionnaire
regarding their preferences for method of blood collection in the neonatal
screening.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
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 | NL48105.018.15 |