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Completed

NCT Number: NCT05033496

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

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillel Yaffe medical center

Hadera, 38100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroid function test

Diagnostic Test

Thyroid function test

Primary outcomes

  1. Hypothyroidism found in local test was missing by national screening test

    Time frame: 10 years

    The proportion of missed hypothyroidism in screening test (missing = found in local test and missed in national screening test)

  2. Hypothyroidism found in screening test was missing in local test

    Time frame: 10 years

    The proportion of missed hypothyroidism in local test (missing = found in national screening test and missed in local test)

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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