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

NCT03390348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2018-08-17

No results posted yet for this study

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

Conditions

  • Crying
  • Fussy Infant (Baby)

Interventions

DEVICE

LENA Recorder

Use of the LENA recorder to document crying and fussing

Sponsors & Collaborators

  • LENA Foundation

    collaborator UNKNOWN
  • ObvioHealth

    collaborator INDUSTRY
  • Danone Asia Pacific Holdings Pte, Ltd.

    lead INDUSTRY

Principal Investigators

  • Parth Shah, MD · Obvio Health

Eligibility

Max Age
15 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2018-05-22
Completion
2018-05-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390348 on ClinicalTrials.gov