Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)

Exclusion Criteria

• •Preterm neonates with a gestational age \< 37 weeks;
• •Low birth weight (LBW) or very low birth weight (VLBW) neonates (weight \< 2.5 kg) or VLBW infants (weight \< 1.5 kg);
• •Neonates in neonatal intensive care units or requiring admission to NICU or neonates/infants hospitalized or requiring hospitalization or in fragile health conditions (e.g. with serious health problems or complications);
• •Neonates with CH diagnosis \> 4 weeks after delivery;
• •Diagnosis of primary gastrointestinal disease:
• •* Gastroesophageal reflux requiring medical therapy (beyond thickening of formula or position);
• •* Anatomic defects (e.g. intestinal atresia, malrotation, tracheoesophageal fistula, pyloric stenosis, Hirschsprung's disease, gastroschisis);
• •* Dietary allergy (e.g. cow's milk protein allergy);
• •* Malabsorption related to cystic fibrosis, celiac disease and others;
• •* Necrotizing enterocolitis requiring surgical resection;
• •Known or suspected adrenal insufficiency (e.g. congenital adrenal hyperplasia, hypopituitarism);
• •Diagnosis of congenital cardiac disease, cardiac insufficiency or risk for cardiac failure;
• •Diagnosis of chromosomopathy;
• •Diagnosis of central hypothyroidism;
• •Hypersensitivity to glycerol;
• •Concomitant anticonvulsant medications, liothyronine, combination of LT4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids
• •History of nonadherence with medication or medical visit schedule; or
• •Any condition for which, participation would not be in the best interest of the patient or that could limit protocol specified assessments.