Abstract
Sleep problems are frequently reported in infants treated with propranolol for infantile hemangiomas, possibly serving as a marker for a negative impact on central nervous system function. In this cohort study, we objectively investigate the sleep behavior of infants with infantile hemangiomas on propranolol compared to a healthy, untreated control group. Sleep of propranolol-treated infants and controls was investigated using ankle actigraphy and a 24-h diary for 7–10 days at ages 3 and 6 months. The main outcome measures were the Number of Nighttime Awakenings and Sleep Efficiency. The main secondary outcome measures included 24-hour Total Sleep, daytime sleep behavior, and parent-rated infant sleep quality and behavioral development based on the Brief Infant Sleep Questionnaire (BISQ) and the age-appropriate Ages-and-Stages Questionnaire (ASQ), respectively. Fifty-four term-born infants were included in each cohort. No group difference in any investigated parameter was seen at age 3 months. At age 6 months, the propranolol group exhibited a decrease in Sleep Efficiency and a trend towards an increased Number of Nighttime Awakenings compared to the control group. Treated infants at 6 months also had shorter daytime waking periods. 24-hour Total Sleep was unaffected by propranolol. No negative impact of propranolol on subjective sleep quality and behavioral development was noted.Conclusion: Propranolol exerts a measurable yet mild impact on objectively assessed infants’ sleep measures. Behavioral developmental scores were unaffected. Our results support propranolol as first-line therapy for complicated infantile hemangiomas.What is Known:• Sleep disorders are frequently reported in infants with infantile hemangiomas treated with propranolol and often lead to treatment discontinuation.• Investigations of the sleep pattern in this patient group using objective measures are lacking.What is New:• The sleep pattern of propranolol-treated infants is assessed using actigraphy and a 24-h sleep diary and compared to healthy, untreated controls.• Propranolol leads to a decreased sleep efficiency at night and an increased demand of daytime sleep, yet effects are mild overall.
Highlights
Systemic propranolol is considered first-line treatment for complicated infantile hemangiomas (IH), given its excellent efficacy and safety [1, 2]
This cohort study consisted of a prospective cohort of infants with propranolol treatment for IH, whose sleep behavior was assessed over time, and a comparison with an identically designed, historical cohort of untreated infants, whose sleep behavior was assessed in the same manner without any temporal matching
We acknowledge that the used methodological approach, notably the use of historical controls, may cause secular biases and other potential distortion. This is the largest study to examine with objective measures whether propranolol treatment of infants with IH is linked to altered sleep behavior
Summary
Systemic propranolol is considered first-line treatment for complicated infantile hemangiomas (IH), given its excellent efficacy and safety [1, 2]. Propranolol can cross the blood-brain barrier, leading to concerns for a potentially negative impact on central nervous system (CNS) function [3, 4]. Intolerable sleep problems are the most frequent reason for early propranolol discontinuation, which may result in a poorer overall outcome of treated IH [9]. Sleep fulfills an essential function in development and is linked to brain maturation, neural reorganization, and processes of learning and memory [10, 11]. While available data on neurocognitive development of propranolol-treated infants with IH is reassuring [12,13,14,15], further investigation of sleep problems and other CNS effects was recommended in a recent review article [6]
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