Comparing different levothyroxine formulations for treating congenital hypothyroidism in newborns
Official title: Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06724224 · Data updated 2026-11-12
This study is testing which of three different forms of levothyroxine—oral solution, liquid drops, or tablets—works best and is safest for newborns with congenital hypothyroidism.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 11 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | April 8, 2024 |
| Main results expected | April 8, 2031 |
| Study ends | October 8, 2031 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT06724224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include newborns diagnosed with congenital hypothyroidism who are receiving treatment at the study center and are under 11 years old.
✕Probably not a fit
Patients with known chromosomal abnormalities or complex syndromes, or those who started therapy at another center, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the efficacy and safety of three different formulations of levothyroxine (oral solution, liquid drops, and tablets) in newborns diagnosed with congenital hypothyroidism. The study will include both a prospective cohort of patients currently receiving treatment and a retrospective cohort of patients who have already been treated. Data on medical history, clinical outcomes, and biochemical markers will be collected to assess the medium- and long-term effects of each formulation. The research is conducted at the Centre for Endocrine-Metabolic Diseases of the Pediatrics Unit in Bologna, Italy.
Why it matters
Potential benefit: If successful, this study could help identify the most effective levothyroxine formulation for managing congenital hypothyroidism in newborns, leading to better health outcomes.
How similar studies have gone: While similar studies have explored levothyroxine formulations, this specific comparison in a pediatric population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Newborn screening test positivity for Congenital Hypothyroidism; Subjects born in Emilia-Romagna region, Italy, and undergoing diagnostic confirmation and initiation of replacement therapy; Diagnosis-confirmed subjects who underwent L-T4 replacement therapy in the first month of life at Center for Endocrine-Metabolic Diseases, Pediatrics Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola, Italy; Age ≤11 years old; Obtaining informed consent from parents and/or legal guardians and assent from minors included in the study. Exclusion Criteria: Known chromosomal abnormalities or complex syndromes; Patients transferred to another center before completion of at least one year of follow-up from the start of therapy; Patients who started therapy at another center.
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Principal investigator: Rita Ortolano, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Rita Ortolano, MD
- Email: rita.ortolano@aosp.bo.it
- Phone: 0512144816
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Understanding brain development in congenital hypothyroidism: comparing affected children, healthy controls, and mild thyroid conditions
This study tests how brain development in children with congenital hypothyroidism compares to similar children without the condition and to kids with a mild thyroid finding.
-
Thyroid size in healthy, full-term newborns
This study tests whether thyroid volume measured by ultrasound in healthy full-term newborns in Italy falls within expected ranges.
-
How congenital hypothyroidism affects development in infants
This project will test neurological status, motor skills, and sensory processing in babies aged 6–18 months who were treated for primary congenital hypothyroidism from birth.
-
OptiThyDose for children with congenital hypothyroidism and Graves' disease
This trial will test whether the OptiThyDose math model helps doctors choose the right thyroid medicine dose for newborns with congenital hypothyroidism and children with Graves' disease.
-
Exploring genetic causes of congenital hypothyroidism
This study looks at the genetic causes of congenital hypothyroidism in babies born in Emilia-Romagna, Italy, to see how different genes might affect their condition and future health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.