TerminatedPhase 4

Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas

Stopped: due to lack of recruitment and follow up compliance

United States52 participantsStarted 2022-06-23

Plain-language summary

The purpose of this study is to assess the baseline sleep pattern disruption for patients starting oral propranolol at the standard BID dosing regimen compared to the control (timolol) group and to determine if there is a significant improvement in the sleep patterns in infants taking oral propranolol on the TID dosing regimen versus the control (timolol) group

Who can participate

Age range18 Months

SexALL

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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

What they're measuring

Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)

Timeframe: 6 months from baseline

Trial details

NCT IDNCT05479123

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2026-02-19

View on ClinicalTrials.gov More Infantile Hemangioma trials