The Yield of Postnatal Thyroid Function Test in the Well Baby Nursery

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05033496
• Other study ID #: 0128-21-HYMC-IL
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: October 3, 2021

Study information

• Verified date: October 2021
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40601
• Est. completion date: October 3, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Diagnostic Test:
• Thyroid function test
Thyroid function test

Locations

Country	Name	City	State
Israel	Hillel Yaffe medical center	H_adera	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Erratum in: Thyroid. 2017 Sep;27(9):1212. — View 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. Review. — View Citation

van Trotsenburg P, Stoupa A, Léger J, Rohrer T, Peters C, Fugazzola L, Cassio A, Heinrichs C, Beauloye V, Pohlenz J, Rodien P, Coutant R, Szinnai G, Murray P, Bartés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothyroidism found in local test was missing by national screening test	The proportion of missed hypothyroidism in screening test (missing = found in local test and missed in national screening test)	10 years
Primary	Hypothyroidism found in screening test was missing in local test	The proportion of missed hypothyroidism in local test (missing = found in national screening test and missed in local test)	10 years