Pattern of CHNCT06051279
Pattern of Congenital Hypothyroidism in Newborns.
An observational study of Pattern of CH, run by Assiut University.
Trial summary
1. Study the pattern of congenital hypothyroidism in newborns after positive newborn screening results. 2. Assess the characteristics of the cases (permanent congenital hypothyroidism and transient neonatal hyperthyrotopinemia). Read more about this study
- Who is it for?
- Ages 15 days to 2 months
- Conditions the study is for
- Pattern of CH
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Aug 2025
- 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 15 days to 2 months
- All sexes
- Child
Study population: Cases: Newborn with TSH (the confirmed raised TSH cases after thyroid hormone screening) within one month after birth, both transient neonatal hyperthyrotropinemia cases and permanent congenital hypothyroidism included in the study.
Who may be able to join
- For the case series study: all positive newborns cases with raised TSH level (the confirmed raised TSH cases after thyroid hormone screening) within one month after birth will be taken during one year.
- For the secondary outcome to study the predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia, control group with matched age and gender with normal TSH at birth according to the neonatal TSH screening will be taken. Matched normal neonates will be selected to be compared with permanent congenital hypothyroidism cases and transient neonatal hyperthrotropinemia cases.
Who cannot join
- Cases that refused to participate in research.
- Cases that missed for follow up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Congenital Hypothyroidism in Newborns in Sidi-Galal Clinic Assiut Governorate.
- Study the pattern of congenital hypothyroidism in newborns after positive newborn screening results.
- Assess the characteristics of the cases (permanent congenital hypothyroidism and transient neonatal hyperthyrotopinemia).
Read the detailed description
Thyroid hormone is essential for normal somatic growth and neurological development in infants and children. Deficiency of thyroid hormone in the first 2 years of life results in congenital hypothyroidism (CH). CH manifests by mental retardation and growth retardation in newborn.
Newborn screening (NS) for CH aims to early diagnosis and treatment of hypothyroidism. CH occurs about one in 3000-4000 infants . CH is suspected in neonatal screening when capillary thyroid-stimulating hormone (TSH) concentrations are elevated (>15 mU/L in Germany). The diagnosis is confirmed by measuring venous TSH and free thyroxine levels (FT4) concentrations before the start of treatment.
CH can be classified into permanent or transient congenital hypothyroidism (TCH). While CH is a persistent deficiency of thyroid hormones that requires lifelong treatment, TCH is a temporary deficiency that reverts to normal concentrations with proper medical management, usually during the first few months of life and not after the age of 3 years.
Transient neonatal hyperthyrotropinemia (TNH) is defined as temporary postnatal elevation of TSH levels (10 mIU/L-20 mIU/L) with normal FT4 levels but TSH returning to normal (<10 mIU/L) when measured at 14 d of life. It is important to recognize TNH as these newborns have a higher risk of developing permanent hypothyroidism with repercussion on developmental status. Thus, we aimed at evaluating the neonatal and maternal factors associated with TNH . So that, identifying these factors may be considered as an appropriate strategy to prevent these possible disorders. There is a gap in studying the prevalence and the predictors of transient neonatal hyperthyrotropinemia particularly in Assiut Governorate.
- Conditions
- Pattern of CH
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 |
|---|---|---|
| Cases with TNH | Newborns with raised TSH level and normal FT4 (the confirmed raised TSH cases after thyroid hormone screening) that return normal without intervention within one month after birth. | |
| Cases with permanent congenital hypothyroidism | Newborns with raised TSH level and low FT4 (confirmed cases after thyroid hormone screening) | |
| Control group | Control group with matched age and gender with normal TSH at birth according to the neonatal TSH screening. Matched normal neonates will be selected to be compared with transient neonatal hyperthrotropinemia cases and permanent congenital hypothyroidism cases for studying of the predictors of transient neonatal hyperthyrotopinemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of congenital hypothyroidism in newborns after positive newborn screening results.
The data will be collected from the records of laboratory investigation to assess the pattern of congenital hypothyroidism
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia as neonatal, obstateric and maternal factors.
Determine if studied neonates on breastfeeding or not and have sufficient feeding signs or not by asking the child caregiver
Measured: through study completion, an average of 1 year
Characteristics of studied newborns in all types of congenital hypothyroidism in Sidi-Galal clinic as in feeding, nutritional status and growth parameters.
Determine if studied neonates on breastfeeding or not and have sufficient feeding signs or not by asking the child caregiver
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pattern of CHStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma El Zahra Fathy Mohamed Abdelhady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051279
- Sponsor's protocol ID
- Pattern of CH
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Congenital Hypothyroidism in Newborns in Sidi-Galal Clinic Assiut Governorate.
- ClinicalTrials.gov ID
- NCT06051279
- Acronym / sponsor ID
- Pattern of CH
- Conditions
- Pattern of CH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Sep 2023 (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.
- Study the pattern of congenital hypothyroidism in newborns after positive newborn screening results.
- Assess the characteristics of the cases (permanent congenital hypothyroidism and transient neonatal hyperthyrotopinemia).
Detailed description
Thyroid hormone is essential for normal somatic growth and neurological development in infants and children. Deficiency of thyroid hormone in the first 2 years of life results in congenital hypothyroidism (CH). CH manifests by mental retardation and growth retardation in newborn.
Newborn screening (NS) for CH aims to early diagnosis and treatment of hypothyroidism. CH occurs about one in 3000-4000 infants . CH is suspected in neonatal screening when capillary thyroid-stimulating hormone (TSH) concentrations are elevated (>15 mU/L in Germany). The diagnosis is confirmed by measuring venous TSH and free thyroxine levels (FT4) concentrations before the start of treatment.
CH can be classified into permanent or transient congenital hypothyroidism (TCH). While CH is a persistent deficiency of thyroid hormones that requires lifelong treatment, TCH is a temporary deficiency that reverts to normal concentrations with proper medical management, usually during the first few months of life and not after the age of 3 years.
Transient neonatal hyperthyrotropinemia (TNH) is defined as temporary postnatal elevation of TSH levels (10 mIU/L-20 mIU/L) with normal FT4 levels but TSH returning to normal (<10 mIU/L) when measured at 14 d of life. It is important to recognize TNH as these newborns have a higher risk of developing permanent hypothyroidism with repercussion on developmental status. Thus, we aimed at evaluating the neonatal and maternal factors associated with TNH . So that, identifying these factors may be considered as an appropriate strategy to prevent these possible disorders. There is a gap in studying the prevalence and the predictors of transient neonatal hyperthyrotropinemia particularly in Assiut Governorate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases with TNH | – | –Newborns with raised TSH level and normal FT4 (the confirmed raised TSH cases after thyroid hormone screening) that return normal without intervention within one month after birth. |
| Cases with permanent congenital hypothyroidism | – | –Newborns with raised TSH level and low FT4 (confirmed cases after thyroid hormone screening) |
| Control group | – | –Control group with matched age and gender with normal TSH at birth according to the neonatal TSH screening. Matched normal neonates will be selected to be compared with transient neonatal hyperthrotropinemia cases and permanent congenital hypothyroidism cases for studying of the predictors of transient neonatal hyperthyrotopinemia. |
Who may qualify
- Ages
- 15 days to 2 months
- Sex
- All
- Age groups
- Child
- Study population
- Cases: Newborn with TSH (the confirmed raised TSH cases after thyroid hormone screening) within one month after birth, both transient neonatal hyperthyrotropinemia cases and permanent congenital hypothyroidism included in the study.
Key inclusion criteria (2 listed)
- For the case series study: all positive newborns cases with raised TSH level (the confirmed raised TSH cases after thyroid hormone screening) within one month after birth will be taken during one year.
- For the secondary outcome to study the predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia, control group with matched age and gender with normal TSH at birth according to the neonatal TSH screening will be taken. Matched normal neonates will be selected to be compared with permanent congenital hypothyroidism cases and transient neonatal hyperthrotropinemia cases.
Key exclusion criteria (2 listed)
- Cases that refused to participate in research.
- Cases that missed for follow up.
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
Pattern of congenital hypothyroidism in newborns after positive newborn screening results.
Time frame: through study completion, an average of 1 year
The data will be collected from the records of laboratory investigation to assess the pattern of congenital hypothyroidism
2 secondary outcomes
Predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia as neonatal, obstateric and maternal factors.
Time frame: through study completion, an average of 1 year
Characteristics of studied newborns in all types of congenital hypothyroidism in Sidi-Galal clinic as in feeding, nutritional status and growth parameters.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pattern of CH, run by Assiut University.
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 2 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Fatma El Zahra Fathy (01005256223, fatma.fathy.mohamed2441997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of congenital hypothyroidism in newborns after positive newborn screening results. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.