Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenita… (NCT05228184) | Clinical Trial Compass
TerminatedPhase 4
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
Stopped: Inability to recruit subjects
United States34 participantsStarted 2022-01-21
Plain-language summary
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.
Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium crushed tablets).
Who can participate
Age range1 Day – 9 Months
SexALL
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Inclusion Criteria:
* Male and female patient aged 0 to 9 months
* Primary CH diagnosis with elevated TSH and low or normal FT4, requiring treatment with LT4, under either of the following conditions:
* Neonates newly diagnosed with primary CH and needing to initiate LT4 therapy, or
* Infants previously diagnosed with primary CH and who are already on LT4 therapy for at least 3 weeks;
* Provide and comply with the informed consent.
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);
*…
What they're measuring
1
LT4 dose required to maintain TSH in target range (unit: mcg/kg/day)