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

Not Applicable

Terminated

Interventions: Device: Weighted Wearable Blanket provided by Dreamland Baby Co.

Brief Summary: The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age.

The main questions it aims to answer are:

Primary Objective: To pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram.

Secondary Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.

Detailed Description: 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 a minimum (10) healthy infants aged 0-12 months with nap polysomnogram. Participants will be placed in a weighted wearable blanket, in accordance with their age/weight/height, by their parent or caregiver under the supervision of a member of the study team. After being put to sleep on their back, the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram.

There are stopping parameters (outlined elsewhere) that will be used for this study. If any of the stopping parameters are met, the weighted blanket will be opened to assess if the weighted blanket is responsible for the change. If determined yes, the weighted blanket will be removed and the nap polysomnogram will be terminated.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pilot	Weighted Wearable Blanket provided by Dreamland Baby Co.	Weighted wearable blanket, provided by Dreamland Baby Co.

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation	Day 1, during polysomnogram, up to 8 hours	Measured by pulse oximetry
Body Temperature	Day 1, during polysomnogram, up to 8 hours	Manually measured by ear thermometer
Respiratory Rate	Day 1, during polysomnogram, up to 8 hours	Measured by Respiratory effort belts
Number of Infants with Observed Body Movement	Day 1, during polysomnogram, up to 8 hours	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
Heart Rate	Day 1, during polysomnogram, up to 8 hours	Measured by EKG
Number of Infants with Observed Arm Movement	Day 1, during polysomnogram, up to 8 hours	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
Number of Infants with Observed Head Movement	Day 1, during polysomnogram, up to 8 hours	The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Riley Hospital for Children at Indiana University Health
🇺🇸
Indianapolis, Indiana, United States