Clinical trial NCT05033496: The Yield of Postnatal Thyroid Function Test in the Well Baby Nursery
Official title: The Yield of Postnatal Thyroid Function Test in Term Newborn Infants in the Well Baby Nursery in Addition to the National Screening Test Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-09-02
Enrollment: 40601
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants born in our medical center

Brief summary: Thyroid function test are performed in the well baby nursery to newborn infants of mothers with hypothyroidism, or as part of neonatal jaundice investigation. As thyroid function test are also part of the national screening test program, the investigators raised the option that the above management is unnecessary, and managed a study to investigate it.

Detailed description: Thyroid function test are performed in the well baby nursery to newborn infants of mothers with hypothyroidism, or as part of neonatal jaundice investigation. As thyroid function test are also part of the national screening test program, the investigators raised the option that the above management is unnecessary, and managed a study to investigate it.

The study is retrospective. About 4000 infants are born in the center every year. The investigators wish to examine data for 10 years, i.e. about 40000 files.

The investigators will collect all the national screening test program results and compare them to the thyroid function test performed in that center.

Eligibility criteria: Inclusion Criteria:

* Infants born in our medical center
* Term infants
* Admitted to well baby nursery and stayed there until discharge

Exclusion Criteria:

* Preterm infants
* Transferred to neonatal intensive care unit for any reason

Primary outcomes:
measure: Hypothyroidism found in local test was missing by national screening test
timeFrame: 10 years
measure: Hypothyroidism found in screening test was missing in local test
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe medical center
state: Hadera
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Trotsenburg P, Stoupa A, Leger J, Rohrer T, Peters C, Fugazzola L, Cassio A, Heinrichs C, Beauloye V, Pohlenz J, Rodien P, Coutant R, Szinnai G, Murray P, Bartes B, Luton D, Salerno M, de Sanctis L, Vigone M, Krude H, Persani L, Polak M. Congenital Hypothyroidism: A 2020-2021 Consensus Guidelines Update-An ENDO-European Reference Network Initiative Endorsed by the European Society for Pediatric Endocrinology and the European Society for Endocrinology. Thyroid. 2021 Mar;31(3):387-419. doi: 10.1089/thy.2020.0333.
citation: Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457.
citation: American Academy of Pediatrics; Rose SR; Section on Endocrinology and Committee on Genetics, American Thyroid Association; Brown RS; Public Health Committee, Lawson Wilkins Pediatric Endocrine Society; Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, Varma SK. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006 Jun;117(6):2290-303. doi: 10.1542/peds.2006-0915.