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

Completed

• Conditions: Crying; Fussy Infant (Baby)

• Registration Number: NCT03390348
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-04
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ObvioHealth; 🇺🇸 Orlando, Florida, United States