Study Finds Propranolol Initiation for Infantile Hemangiomas Safe with Less Monitoring

A recent study evaluated the safety and clinical outcomes of initiating propranolol in hospitalized pediatric patients with infantile hemangiomas and identified potential complications associated with inpatient monitoring.¹

According to the retrospective analysis, published in Pediatric Dermatology, propranolol initiation results in clinically insignificant changes to blood pressure and heart rate in infants, and no symptomatic hypoglycemia was observed. These findings suggest that inpatient monitoring may be less intensive than currently practiced, with implications for optimizing care protocols.

Image Credit: © Aisylu - stock.adobe.com

Background and Methods

The use of propranolol is well-documented as safe and effective in infantile hemangiomas, particularly for infants aged 5 weeks and older.² However, its initiation in patients younger than 5 weeks, those with a history of prematurity, or those with low birth weight often requires hospitalization to monitor heart rate, blood pressure, and glucose levels.²

With this in mind, researchers sought to assess whether the standard monitoring for adverse events during propranolol initiation was necessary, and to evaluate the safety of the current practice.

The present study was a retrospective chart review conducted on patients seen at the University of Minnesota Department of Dermatology between January 1, 2012, and July 31, 2022. Inclusion criteria were infants under 1 year of age diagnosed with infantile hemangiomas and/or PHACE syndrome, who were admitted for propranolol initiation.

Findings

A total of 78 pediatric patients met the inclusion criteria. The cohort predominantly consisted of White (64.1%), female (78.2%) infants. Of these, 73.1% weighed less than 5 kg, 52.6% were born at term, and 86.4% had fewer than 5 hemangiomas. The average initial propranolol dose was 1.60 ± 0.68 mg/kg/day, typically administered in 3 doses.

Upon initiation of propranolol, researchers observed statistically significant decreases in systolic blood pressure, diastolic blood pressure, and heart rate. Specifically, systolic blood pressure decreased from 95.7 ± 11.2 mmHg to 91.1 ± 10.5 mmHg, diastolic blood pressure decreased from 55.7 ± 10.4 mmHg to 51.1 ± 9.8 mmHg, and heart rate decreased from 146.0 ± 16.4 bpm to 131.6 ± 12.2 bpm.

While these changes were statistically significant, the average blood pressure and heart rate post-initiation remained within normal pediatric ranges, meaning the above findings were clinically insignificant.

One of the key findings observed was that no patients experienced symptomatic hypoglycemia during the monitoring period. Glucose levels were assessed prior to dosing and after the longest fasting period, but no changes to the dosing protocol were required based on glucose levels. No symptomatic episodes of hypotension or bradycardia were observed in the cohort, further supporting the safety of propranolol initiation in an inpatient setting for these patients.

Additionally, subgroup analyses revealed no statistically significant differences in vital sign changes based on weight, gestational age, or corrected age. These findings suggest that the degree of monitoring, especially for patients weighing less than 5 kg or those born prematurely, may not need to be as intensive as currently practiced. The average length of hospitalization for patients in this cohort was 1.6 ± 1.7 days, with patients diagnosed with PHACE syndrome requiring slightly longer stays (3.5 ± 0.55 days).

Conclusions and Future Directions

This study confirms that propranolol initiation for infantile hemangiomas in hospitalized patients is safe, with no symptomatic complications observed related to vital sign changes or hypoglycemia.

These results suggest that strict inpatient monitoring for adverse events may be unnecessary, particularly in the absence of risk factors such as extreme low weight, prematurity, or PHACE syndrome, according to study authors Rypka et al.

There are several limitations to the study that should be considered when interpreting these results, according to researchers, including its retrospective design, single-center nature, and relatively small sample size.

"Our findings complement current literature suggesting that propranolol initiation for [infantile hemangioma] management has few complications even in patients <5-week-corrected-age and those weighing <5 kg," wrote Rypka et al. "Oral propranolol initiation likely requires less monitoring than currently performed."

References

1. Rypka K, Bellefeuille G, Wendland Z, Paiewonsky B, Freese R, Maguiness S, Nicholson C. Oral propranolol and its impact on vital signs in hospitalized pediatric patients for the management of infantile hemangiomas. Pediatr Dermatol. 2025 Feb 18. doi: 10.1111/pde.15740
2. Fu R, Zou Y, Wu Z, Jin P, Cheng J, Bai H, Huang M, Huan X, Yuan H. Safety of oral propranolol for neonates with problematic infantile hemangioma: a retrospective study in an Asian population. Sci Rep. 2023 Apr 12;13(1):5956. doi: 10.1038/s41598-023-33105-2