Impact of Propranolol Dosage on Sleep in Infants with Hemangiomas
Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas
This study tests if giving infants with hemangiomas propranolol three times a day helps them sleep better compared to the usual twice-a-day dose or a different medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | N/A to 18 Months |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05479123 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different dosing frequencies of propranolol affect sleep patterns in infants diagnosed with infantile hemangiomas. It compares the standard twice-daily dosing regimen to a control group receiving timolol, and assesses whether a three-times-daily dosing regimen leads to significant improvements in sleep quality. The study aims to provide insights into the optimal dosing strategy for enhancing sleep in these patients.
Who should consider this trial
Good fit: Ideal candidates are infants with clinically diagnosed hemangiomas who are English or Spanish speaking.
Not a fit: Patients with significant cardiac or pulmonary diseases that prevent them from tolerating oral propranolol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep patterns in infants treated for hemangiomas, enhancing their overall quality of life.
How similar studies have performed: While there is limited information on similar studies, the approach of assessing medication impact on sleep patterns in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically diagnosed hemangiomas. * English or Spanish speaking only Exclusion Criteria: * Parents who do not consent to the study. * Significant cardiac or pulmonary disease who are unable to tolerate oral propranolol
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Matthew R Greives, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Matthew R Greives, MD
- Email: Matthew.R.Greives@uth.tmc.edu
- Phone: 713-500-7275
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.