Liquid vs crushed pills: which works better for babies with low thyroid?
NCT ID NCT05228184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared a liquid form of thyroid medication (Tirosint-SOL) to crushed tablets in 34 infants with congenital hypothyroidism. The goal was to see which form helps maintain normal thyroid hormone levels more easily. However, the study was stopped early, so firm conclusions cannot be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- levothyroxine (thyroid hormone)
- What this could lead to
- If successful, this could show that a liquid form of thyroid medication is easier to dose accurately in infants than crushed tablets.
- What could go wrong
- The trial was terminated early with only 34 out of 126 planned participants, so results may be incomplete and not reliable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
34 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
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Mar 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 day to 9 months
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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); * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
-
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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CHOC Children's Hospital
Orange, California, 92868, United States
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Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Children's Hospital of Atlanta
Atlanta, Georgia, 30329, United States
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Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
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Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64111, United States
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Cook Children's Health Care Systems
Fort Worth, Texas, 76104, United States
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University of California San Francisco
San Francisco, California, 94143, United States
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Yale University
New Haven, Connecticut, 06511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Newborn screening study aims to catch rare diseases at birth
- New study to map normal thyroid size in italian newborns
- New liquid thyroid drug tested in infants: could it be better?
- DNA detective work: why some babies have lifelong thyroid problems
- Extra blood tests could spot thyroid issues in preemies sooner