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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05033496
Collaborator
(none)
40,601
1
129.1
314.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Thyroid function test

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.

Study Design

Study Type:
Observational
Actual Enrollment :
40601 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Oct 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Newborn infants

Newborn infants born in our medical center

Diagnostic Test: Thyroid function test
Thyroid function test

Outcome Measures

Primary Outcome Measures

  1. Hypothyroidism found in local test was missing by national screening test [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 [10 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hillel Yaffe medical center H̱adera Hadera Israel 38100

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Erez Nadir, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erez Nadir, MD, Neonatologist, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT05033496
Other Study ID Numbers:
  • 0128-21-HYMC-IL
First Posted:
Sep 2, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021