Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep

Launched by INDIANA UNIVERSITY · May 15, 2024

Keywords

ClinConnect Summary

To date, there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature. These are the conditions in which these products are used by consumers, with infants sleeping unobserved throughout the night. Given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated, a study of the potential impact of weighted wearable blankets on infant vital signs is warranted.

Study Design: Direct observational pilot study of the safety of weighted wearable blankets on ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study
• • 0-12 months of age
• • Weight greater than or equal to 8 pounds
• • Gestational age 37 weeks or greater
• • Health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders
• • Infant is naive to a weighted wearable blanket
• Exclusion Criteria:
• • Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder
• • Weight \< 8 pounds
• • Gestational age \< 37 weeks
• • Gestational use of marijuana, alcohol, or illicit drugs
• • Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana
• • Infant is not naive to a weighted wearable blanket

Trial Officials