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| ID | Type | Description | Link |
|---|---|---|---|
| EBB17GC16811 | Other Identifier | DAPH |
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| Name | Class |
|---|---|
| LENA Foundation | UNKNOWN |
| ObvioHealth | INDUSTRY |
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This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to compare infant crying and fussing parameters documented by the LENA recorder with those documented via parental e-diaries
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LENA Recorder | Device | Use of the LENA recorder to document crying and fussing |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries | Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries | Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries | 14 days |
| Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder |
| Measure | Description | Time Frame |
|---|---|---|
| Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface | Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface | 14 days |
| Using a parental questionnaire, investigate the usability of the LENA recording device |
Inclusion Criteria:
Exclusion Criteria:
Infants:
Parents/Guardians of infants:
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Healthy term infants of ≤15 weeks of age
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah, MD | Obvio Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ObvioHealth | Orlando | Florida | 32826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22751753 | Background | Dykstra JR, Sabatos-Devito MG, Irvin DW, Boyd BA, Hume KA, Odom SL. Using the Language Environment Analysis (LENA) system in preschool classrooms with children with autism spectrum disorders. Autism. 2013 Sep;17(5):582-94. doi: 10.1177/1362361312446206. Epub 2012 Jul 2. | |
| 26174716 | Result | Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8. |
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Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder |
| 14 days |
Using a parental questionnaire, investigate the usability of the LENA recording device |
| 14 days |
| Explore possible correlations between crying and fussing behaviors and infant diet reports | Explore possible correlations between crying and fussing behaviors and infant diet reports | 14 days |
| ID | Term |
|---|---|
| D003448 | Crying |
| ID | Term |
|---|---|
| D009633 | Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |
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