An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries

Study Overview
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Brief Summary
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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

Official Title
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An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries

Conditions
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Crying, Fussy Infant (Baby)

Intervention / Treatment
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* Device: LENA Recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term infants, age ≤15 weeks Singleton infants (≥37 and ≤42 weeks gestation) Birth weight within normal range for gender and gestational age Informed consent from parent or legal guardian whose age is ≥18 years old Live in a household with reliable electronic communication capability (e.g. smart phone, computer, internet access) Infants who are breastfed and/or are consuming any commercial infant formula as a major nutrient source Parent's/guardian's English literacy sufficient to follow instructions and complete forms Exclusion Criteria: Infants: Currently or within last 30 days prior to screening, participation in any other investigational studies Known to have current or previous illness/condition which could interfere with the study outcome, as per Investigator's clinical judgment Parents/Guardians of infants: Known to have a significant medical condition (including during pregnancy) that might interfere with the study, as per Investigator's clinical judgment Inability to comply with study protocol, as per the Investigator's judgement

Ages Eligible for Study
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Maximum Age: 15 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LENA Recorder|Use of the LENA recorder to document crying and fussing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder | 14 days |