Congenital HypothyroidismNCT04712760
Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
An observational study of Congenital Hypothyroidism, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Read more about this study
- Who is it for?
- Ages Up to 42 months
- Conditions the study is for
- Congenital Hypothyroidism
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2021to 1 Apr 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 42 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital hypothyroidism either detected by newborn screening or by a blood test done because of clinical suspicion of hypothyroidism, in Lorraine, between 1996 and 2017. All the patients with confirmed hypothyroidism underwent thyroid imaging. The children with eutopic gland and hemiagenesis are included in this study.
Who may be able to join
- Children with congenital hypothyroidism
- Eutopic thyroid gland or thyroid hemiagenesis
- Born between 1996 and 2017
- Treated at the Nancy Regional and University Hospital
- Follow-up of at least 3,5 years.
Who cannot join
- Polymalformative syndrome
- Thyroid dysgenesis except for thyroid hemiagenesis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy, 54000
Emeline Renard, MD, +33 3 83 15 45 00, e.renard@chru-nancy.fr
Sylvie Hélène Bontemps
About this study
In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
- Conditions
- Congenital Hypothyroidism
- Keywords
- eutopic thyroid gland, transient hypothyroidism
- Medical subject headings
- Congenital Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transient congenital hypothyroidism | - children with congenital hypothyroidism who are no longer treated with Levothyroxine at an age of 3 years and 6 months | |
| Permanent congenital hypothyroidism | - children with congenital hypothyroidism who are still treated with Levothyroxine at an age of 3 years and 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
Measured: 42 months
Secondary outcomes (3)
Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up.
Measured: 6 months, 1 year, 2 years, 3 years
Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.
Measured: 42 months
Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start22 Feb 2021
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENARD Emeline, Central Hospital, Nancy, France
- Investigators
- Emeline Renard, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712760
- Sponsor's protocol ID
- 2020PI260
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bontemps SH, Legagneur C, Gueant-Rodriguez RM, Remen T, Luc A, Renard E. Congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis: prognostic factors for transient vs. permanent hypothyroidism. J Pediatr Endocrinol Metab. 2023 Feb 20;36(4):353-363. doi: 10.1515/jpem-2022-0101. Print 2023 Apr 25.
PubMed 36798001
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
- ClinicalTrials.gov ID
- NCT04712760
- Acronym / sponsor ID
- 2020PI260
- Conditions
- Congenital Hypothyroidism
- Keywords
- eutopic thyroid gland, transient hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 15 Jan 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.
In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transient congenital hypothyroidism | – | –- children with congenital hypothyroidism who are no longer treated with Levothyroxine at an age of 3 years and 6 months |
| Permanent congenital hypothyroidism | – | –- children with congenital hypothyroidism who are still treated with Levothyroxine at an age of 3 years and 6 months |
Who may qualify
- Ages
- Up to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital hypothyroidism either detected by newborn screening or by a blood test done because of clinical suspicion of hypothyroidism, in Lorraine, between 1996 and 2017. All the patients with confirmed hypothyroidism underwent thyroid imaging. The children with eutopic gland and hemiagenesis are included in this study.
Key inclusion criteria (5 listed)
- Children with congenital hypothyroidism
- Eutopic thyroid gland or thyroid hemiagenesis
- Born between 1996 and 2017
- Treated at the Nancy Regional and University Hospital
- Follow-up of at least 3,5 years.
Key exclusion criteria (2 listed)
- Polymalformative syndrome
- Thyroid dysgenesis except for thyroid hemiagenesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
Time frame: 42 months
3 secondary outcomes
Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up.
Time frame: 6 months, 1 year, 2 years, 3 years
Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.
Time frame: 42 months
Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).
Time frame: 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 36798001Bontemps SH, Legagneur C, Gueant-Rodriguez RM, Remen T, Luc A, Renard E. Congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis: prognostic factors for transient vs. permanent hypothyroidism. J Pediatr Endocrinol Metab. 2023 Feb 20;36(4):353-363. doi: 10.1515/jpem-2022-0101. Print 2023 Apr 25.
- Individual participant dataSharing planned: Undecided
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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.
Emeline Renard, MD principal investigator
CHRU Nancy
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 Congenital Hypothyroidism, run by Central Hospital, Nancy, France at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emeline Renard, MD (+33 3 83 15 45 00, e.renard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis. (time frame: 42 months). 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 NCT04712760, which also lists 1 linked publication.
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 23 Feb 2021.