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Liquid vs crushed pills: which works better for babies with low thyroid?

NCT ID NCT05228184

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • CHOC Children's Hospital

    Orange, California, 92868, United States

  • Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Children's Hospital of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Mercy Hospital and Clinics

    Kansas City, Missouri, 64111, United States

  • Cook Children's Health Care Systems

    Fort Worth, Texas, 76104, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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