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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-22

Study Completion Date

2018-05-22

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

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Detailed Description

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Conditions

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Crying Fussy Infant (Baby)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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LENA Recorder

Use of the LENA recorder to document crying and fussing

Intervention Type DEVICE

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

Maximum Eligible Age

15 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes