Status:
COMPLETED
An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
LENA Foundation
ObvioHealth
Conditions:
Crying
Fussy Infant (Baby)
Eligibility:
All Genders
Up to 15 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03390348
Start Date
November 22 2017
End Date
May 22 2018
Last Update
August 17 2018
Active Locations (1)
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1
ObvioHealth
Orlando, Florida, United States, 32826