Final Height in Patients With CH Diagnosed by the Screening

NCT04734457 | Unknown

• 1 other identifier: Final height in CH patients
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Hypothyroidism

Keywords

Final Height; Neonatal screening

Outcome Measures

Primary Outcomes (1)

• Assessment of change of Final Height in patients with Congenital Hypothyroidism diagnosed by neonatal screening

  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).

Interventions

Levothyroxin DRUG

We assess the effect of early diagnosis of CH by neonatal screening and start of treatment on the final height of the patients

Also known as: neonatal screening

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasiya, 1181, Egypt

Location

Related Publications (12)

• Bain P, Toublanc JE. Adult height in congenital hypothyroidism: prognostic factors and the importance of compliance with treatment. Horm Res. 2002;58(3):136-42. doi: 10.1159/000064489.

  PMID: 12218379 BACKGROUND

• Bassett JH, Williams AJ, Murphy E, Boyde A, Howell PG, Swinhoe R, Archanco M, Flamant F, Samarut J, Costagliola S, Vassart G, Weiss RE, Refetoff S, Williams GR. A lack of thyroid hormones rather than excess thyrotropin causes abnormal skeletal development in hypothyroidism. Mol Endocrinol. 2008 Feb;22(2):501-12. doi: 10.1210/me.2007-0221. Epub 2007 Oct 11.

  PMID: 17932107 RESULT

• Bauer AJ, Wassner AJ. Thyroid hormone therapy in congenital hypothyroidism and pediatric hypothyroidism. Endocrine. 2019 Oct;66(1):51-62. doi: 10.1007/s12020-019-02024-6. Epub 2019 Jul 26.

  PMID: 31350727 RESULT

• Cole TJ, Freeman JV, Preece MA. Body mass index reference curves for the UK, 1990. Arch Dis Child. 1995 Jul;73(1):25-9. doi: 10.1136/adc.73.1.25.

  PMID: 7639544 RESULT

• Dickerman Z, De Vries L. Prepubertal and pubertal growth, timing and duration of puberty and attained adult height in patients with congenital hypothyroidism (CH) detected by the neonatal screening programme for CH--a longitudinal study. Clin Endocrinol (Oxf). 1997 Dec;47(6):649-54. doi: 10.1046/j.1365-2265.1997.3181148.x.

  PMID: 9497870 RESULT

• Huffmeier U, Tietze HU, Rauch A. Severe skeletal dysplasia caused by undiagnosed hypothyroidism. Eur J Med Genet. 2007 May-Jun;50(3):209-15. doi: 10.1016/j.ejmg.2007.02.002. Epub 2007 Mar 12.

  PMID: 17433800 RESULT

• Nilsson O, Marino R, De Luca F, Phillip M, Baron J. Endocrine regulation of the growth plate. Horm Res. 2005;64(4):157-65. doi: 10.1159/000088791. Epub 2005 Oct 4.

  PMID: 16205094 RESULT

• Salerno M, Micillo M, Di Maio S, Capalbo D, Ferri P, Lettiero T, Tenore A. Longitudinal growth, sexual maturation and final height in patients with congenital hypothyroidism detected by neonatal screening. Eur J Endocrinol. 2001 Oct;145(4):377-83. doi: 10.1530/eje.0.1450377.

  PMID: 11580992 RESULT

• Tanner JM, Goldstein H, Whitehouse RH. Standards for children's height at ages 2-9 years allowing for heights of parents. Arch Dis Child. 1970 Dec;45(244):755-62. doi: 10.1136/adc.45.244.755.

  PMID: 5491878 RESULT

• Whitney GA, Kean TJ, Fernandes RJ, Waldman S, Tse MY, Pang SC, Mansour JM, Dennis JE. Thyroxine Increases Collagen Type II Expression and Accumulation in Scaffold-Free Tissue-Engineered Articular Cartilage. Tissue Eng Part A. 2018 Mar;24(5-6):369-381. doi: 10.1089/ten.TEA.2016.0533. Epub 2017 Jul 7.

  PMID: 28548569 RESULT

• Williams GR. Role of thyroid hormone receptor-alpha1 in endochondral ossification. Endocrinology. 2014 Aug;155(8):2747-50. doi: 10.1210/en.2014-1527. No abstract available.

  PMID: 25036648 RESULT

• Williams GR, Bassett JHD. Thyroid diseases and bone health. J Endocrinol Invest. 2018 Jan;41(1):99-109. doi: 10.1007/s40618-017-0753-4. Epub 2017 Aug 29.

  PMID: 28853052 RESULT

MeSH Terms

Conditions

Congenital Hypothyroidism

Interventions

Thyroxine; Neonatal Screening

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Mass Screening; Investigative Techniques; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Wessam Mouharram, PhD

  Ain Shams University

  STUDY DIRECTOR

• Rana Mahmoud, PhD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Nader, M.B., B.Ch.

CONTACT

+201014397938; moh.nader90@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 2, 2021
• Study Start: November 2, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

EG (1)