Final Height in Patients With CH Diagnosed by the Screening

October 1, 2021 updated by: Mohamed Nader, Ain Shams University

Final Height in Patients With Congenital Hypothyroidism Diagnosed by Neonatal Screening

The aim of this study is to evaluate longitudinal growth and final height in patients with Congenital Hypothyroidism detected by neonatal screening and factors affecting it.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Linear growth and final height are reported as rather normal in patients with CH diagnosed through the screening and the target height is the most important factor determining linear growth. Data on final height in patients with CH suggest that adult height is significantly correlated with parental height and the mean L-Thyroxine daily dose administered over the first 6 months of treatment. The lowest recommended dose during this period is 8.5μg/kg/day. Periodical adjustments of L-Thyroxine daily dose should be guided by clinical observation and serum free T4 levels.

To our knowledge this is the first study from our center to assess final height in patients with congenital hypothyroidism diagnosed through the Egyptian neonatal screening program.

A complex network of endocrine signals stimulates the process of longitudinal growth including growth hormone, insulin-like growth factor-1, glucocorticoids, thyroid hormone, estrogen, androgens, vitamin D and leptin.

Thyroid hormones are essential for development and normal bone growth. Biochemical studies have shown that thyroid hormones can affect the expression of various bone markers in the serum, reflecting changes in bone remodeling which involves both osteoblastic and osteoclastic activities.

Thyroid hormones act through chondrocytes bearing thyroid hormone receptors (TRs) to modulate growth plate proliferation, differentiation and vascular invasion. Several mechanisms mediate these functions including direct action on the chondrocytes, osteoblasts and mast cells. It also works through interaction with other hormones and growth factors acting in endocrine, paracrine and autocrine fashions.

Overall, T3 acts via TRα in chondrocytes and osteoblasts to regulate intramembranous and endochondral ossification and control the rate of linear growth, bone maturation and mineralization,T4 induces the expression of both type II and X collagen and chondrocyte hypertrophy.

Hypothyroidism in children causes growth arrest, delayed bone maturation, and epiphyseal dysgenesis that can result in short stature and delayed closure of the epiphyses.

In severe undiagnosed cases, complete post-natal growth arrest and skeletal dysplasia occurs with characteristic X-ray features including stippled epiphyses reflecting epiphyseal dysgenesis, congenital hip dislocation, vertebral immaturity, scoliosis, patent fontanelles and sutures and delayed eruption of teeth.

Prompt treatment of patients suffering from CH with thyroid hormone replacement induces a period of rapid catch-up growth in which skeletal maturation and bone age are also accelerated. Ultimately, normal adult height can be expected.

It is controversial whether factors as the degree of hypothyroidism at diagnosis, the timing of the onset of treatment and the doses of replacement L-thyroxine (L-T4) affect linear growth in children with congenital hypothyroidism, detected by screening and treated from early infancy

Study Type

Observational

Enrollment (Anticipated)

60

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

Study Locations

  • Egypt
    • Abbasiya
      • Cairo, Abbasiya, Egypt, 1181
        • ain shams University

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients suffering from CH diagnosed by Egyptian neonatal screening program and have a documented history of CH who received treatment at endocrinology clinic, Children's Hospital, Ain Shams University.

Description

Inclusion Criteria:

  • Patients having a documented history of CH diagnosed by Egyptian neonatal screening program.
  • Patients receiving L-thyroxine (L-T4) since the diagnosis is established.

Exclusion Criteria:

  • Patients who are non-compliant on L-thyroxine (L-T4) and failed to follow up at the clinic on regular basis.
  • Patients who were missed from diagnosis by neonatal screening.
  • Patients with associated hormonal disorders affecting same parameters concerned in the study.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change of Final Height in patients with Congenital Hypothyroidism diagnosed by neonatal screening
Time Frame: Since the diagnosis is established by neonatal screening during first week of life height will be assessed every 6 months with follow up throughout the study period until the study subject reaches an average of 18 years of age( final height reached).
The investigators assess the effect of early diagnosis and early levothyroxine start on the change in longitudinal growth in patients with Congenital Hypothyroidism.
Since the diagnosis is established by neonatal screening during first week of life height will be assessed every 6 months with follow up throughout the study period until the study subject reaches an average of 18 years of age( final height reached).

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Wessam Mouharram, PhD, ain shams University
  • Study Director: Rana Mahmoud, PhD, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

November 2, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Final height in CH patients

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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