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

NCT05033496 | Completed

• 1 other identifier: 0128-21-HYMC-IL
• Study Type: observational
• Target: 40,601
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Newborn infants

Newborn infants born in our medical center

Diagnostic Test: Thyroid function test

Interventions

Thyroid function test DIAGNOSTIC_TEST

Thyroid function test

Newborn infants

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants born in our medical center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (3)

• 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.

  PMID: 33272083 BACKGROUND

• 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.

  PMID: 28056690 BACKGROUND

• 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.

  PMID: 16740880 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroid Function Tests

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Endocrine; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Erez Nadir, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: October 3, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)