Pattern of Congenital Hypothyroidism in Newborns.

September 26, 2023 updated by: Fatma El Zahra Fathy Mohamed Abdelhady, Assiut University

Pattern of Congenital Hypothyroidism in Newborns in Sidi-Galal Clinic Assiut Governorate.

  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).

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Cases that refused to participate in research.
  • Cases that missed for follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Determine if studied neonates on breastfeeding or not and have sufficient feeding signs or not by asking the child caregiver
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
Determine if studied neonates on breastfeeding or not and have sufficient feeding signs or not by asking the child caregiver
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pattern of CH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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