Comparing different levothyroxine formulations for treating congenital hypothyroidism in newborns
Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06724224
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | N/A to 11 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06724224 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include newborns diagnosed with congenital hypothyroidism who are receiving treatment at the study center and are under 11 years old.
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.
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 performed: While similar studies have explored levothyroxine formulations, this specific comparison in a pediatric population is relatively novel.
Eligibility criteria
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 this trial is running
Bologna, Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Hypothyroidism