HypothyroidismNCT05033496
The Yield of Postnatal Thyroid Function Test in the Well Baby Nursery
An observational study of Hypothyroidism, run by Hillel Yaffe Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Thyroid function test
- How many people
- 40,601 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2011to 3 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants born in our medical center
Who may be able to join
- Infants born in our medical center
- Term infants
- Admitted to well baby nursery and stayed there until discharge
Who cannot join
- Preterm infants
- Transferred to neonatal intensive care unit for any reason
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypothyroidism
- Being tested
- Thyroid function test
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid function testDiagnostic test
Thyroid function test
| Study group | Role | What they receive |
|---|---|---|
| Newborn infants | Newborn infants born in our medical center Receives: Diagnostic Test: Thyroid function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2011
- Primary completion31 Dec 2020
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033496
- Sponsor's protocol ID
- 0128-21-HYMC-IL
- Status last verified
- Oct 2021
- First submitted
- 25 Aug 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be erased.
Publications
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.
PubMed 33272083Alexander 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.
PubMed 28056690American 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.
PubMed 16740880
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05033496
- Acronym / sponsor ID
- 0128-21-HYMC-IL
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,601 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn infants | – | Diagnostic Test: Thyroid function testNewborn infants born in our medical center |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants born in our medical center
Key inclusion criteria (3 listed)
- Infants born in our medical center
- Term infants
- Admitted to well baby nursery and stayed there until discharge
Key exclusion criteria (2 listed)
- Preterm infants
- Transferred to neonatal intensive care unit for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid function testThyroid function test | Diagnostic test | Newborn infants |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 33272083van 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.
- Background: PubMed 28056690Alexander 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.
- Background: PubMed 16740880American 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.
- Individual participant dataSharing planned: No. Individual participant data will be erased.
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Hypothyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erez Nadir, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothyroidism found in local test was missing by national screening test (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033496, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.