Crying, Fussy Infant (Baby)
Conditions
Brief summary
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
Interventions
DEVICELENA Recorder
Use of the LENA recorder to document crying and fussing
Sponsors
LENA Foundation
ObvioHealth
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries | 14 days | Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 based on parental e-diaries |
| Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder | 14 days | Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 e-diary and ClaimIt app interface |
| Using a parental questionnaire, investigate the usability of the LENA recording device | 14 days | Using a parental questionnaire, investigate the usability of the LENA recording device |
| Explore possible correlations between crying and fussing behaviors and infant diet reports | 14 days | Explore possible correlations between crying and fussing behaviors and infant diet reports |
Countries
United States
Outcome results
None listed