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External to study controversy has arisen around safety of the product. Due to concerns raised by USCPSC and the AAP, the PI has terminated site participation.
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| Name | Class |
|---|---|
| Dreamland Baby Co. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nap Polysomnogram | Experimental | All healthy infants under 3 months of age that met inclusion criteria were assigned to complete a nap polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
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| Overnight Polysomnogram | Experimental | All healthy infants over 3 months of age that met inclusion criteria were assigned to complete an overnight polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted Wearable Blanket provided by Dreamland Baby Co. | Device | All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Heart Rate | Measured by EKG | Day 1, during polysomnogram, up to 8 hours |
| Average Respiratory Rate | Measured by Respiratory effort belts | Day 1, during polysomnogram, up to 8 hours |
| Average Body Temperature | Manually measured by ear thermometer | Day 1, during polysomnogram, up to 8 hours |
| Average Oxygen Saturation | Measured by pulse oximetry | Day 1, during polysomnogram, up to 8 hours |
| Number of Infants With Observed Head Movement | 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. | Day 1, during polysomnogram, up to 8 hours |
| Number of Infants With Observed Arm Movement | 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. | Day 1, during polysomnogram, up to 8 hours |
| Number of Infants With Observed Body Movement | 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. | Day 1, during polysomnogram, up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep | The study was closed before any overnight studies were completed; therefore, no data for this objective was collected. | Day 1, during polysomnogram, up to 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harish Rao, MD | Riley Hospital for Children at Indiana University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
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6 enrolled participants met inclusion criteria; 4 enrolled participants completed the nap polysomnogram; 2 enrolled participants were withdrawn due to study closure prior to scheduled overnight polysomnogram dates. Those that completed the nap polysomnogram also completed a one-week post survey.
The Dreamland Baby website utilized a link for potential participants to express their interest in the study. A member of the study team made contact by email and then telephone to conduct a recruitment/screening questionnaire. A nap polysomnogram was scheduled during daytime hours for participants that met inclusion criteria and were under 3 months of age. Infants that met inclusion criteria and were greater than 3 months of age were scheduled for an overnight polysomnogram.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nap Polysomnogram | All healthy infants under 3 months of age that met inclusion criteria were assigned to complete a nap polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
| FG001 | Overnight Polysomnogram | All healthy infants over 3 months of age that met inclusion criteria were assigned to complete an overnight polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nap Polysomnogram | All healthy infants under 3 months of age that met inclusion criteria were assigned to complete a nap polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
| BG001 | Overnight Polysomnogram |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Time of Informed Consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Heart Rate | Measured by EKG | The study was closed before participants could complete the overnight polysomnogram. | Posted | Mean | Standard Deviation | beats per minute | Day 1, during polysomnogram, up to 8 hours |
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Adverse event data was collected after informed consent was signed until the one-week post survey was completed. The maximum amount of time participants spent in the study was 37 days, which included signing the informed consent, completing the nap polysomnogram and completing the one-week post survey.
On the one-week post survey, parents were asked if their child had experienced any changes in their baseline health. If parent response was yes, parent was invited to describe what was experienced. A staff member then interviewed parent to collect adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nap Polysomnogram | All healthy infants under 3 months of age that met inclusion criteria were assigned to complete a nap polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Eye Discharge | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harish Rao, Assistant Professor of Clinical Pediatrics | Indiana University | 317-948-7208 | harirao@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2024 | Apr 10, 2025 | Prot_SAP_000.pdf |
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| Weighted Wearable Blanket provided by Dreamland Baby Co. | Device | All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete an overnight polysomnogram. |
|
All healthy infants over 3 months of age that met inclusion criteria were assigned to complete an overnight polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Average Respiratory Rate | Measured by Respiratory effort belts | The study was closed before participants could complete the overnight polysomnogram. | Posted | Mean | Standard Deviation | respirations per minute | Day 1, during polysomnogram, up to 8 hours |
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| Primary | Average Body Temperature | Manually measured by ear thermometer | The study was closed before participants could complete the overnight polysomnogram. | Posted | Mean | Standard Deviation | average body temperature, Celsius | Day 1, during polysomnogram, up to 8 hours |
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| Primary | Average Oxygen Saturation | Measured by pulse oximetry | The study was closed before participants could complete the overnight polysomnogram. | Posted | Mean | Standard Deviation | oxygen saturation percentage | Day 1, during polysomnogram, up to 8 hours |
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| Primary | Number of Infants With Observed Head Movement | 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. | The study was closed before participants could complete the overnight polysomnogram. | Posted | Count of Participants | Participants | Day 1, during polysomnogram, up to 8 hours |
|
|
|
| Primary | Number of Infants With Observed Arm Movement | 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. | The study was closed before participants could complete the overnight polysomnogram. | Posted | Count of Participants | Participants | Day 1, during polysomnogram, up to 8 hours |
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|
|
| Primary | Number of Infants With Observed Body Movement | 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. | The study was closed before participants could complete the overnight polysomnogram. | Posted | Count of Participants | Participants | Day 1, during polysomnogram, up to 8 hours |
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| Secondary | Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep | The study was closed before any overnight studies were completed; therefore, no data for this objective was collected. | No overnight studies were completed; therefore, no data for this objective was collected. | Posted | Day 1, during polysomnogram, up to 12 hours |
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| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Overnight Polysomnogram | All healthy infants over 3 months of age that met inclusion criteria were assigned to complete an overnight polysomnogram while wearing a weighted wearable blanket provided by Dreamland Baby Co. | 0 | 2 | 0 | 2 | 0 | 2 |
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