An observational study in Pattern of CH, sponsored by Assiut University. Not yet recruiting. Open to participants aged 15 Days to 2 Months. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Assiut University · Observational
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.
25 studies on the registry are indexed under Congenital Hypothyroidism; 9 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 13 observational studies indexed under Congenital Hypothyroidism.
Browse Congenital Hypothyroidism studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Exclusion Criteria:
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.
Newborns with raised TSH level and low FT4 (confirmed cases after thyroid hormone screening)
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.
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
Time frame: through study completion, an average of 1 year
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
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.
Determine if studied neonates on breastfeeding or not and have sufficient feeding signs or not by asking the child caregiver
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Assiut University