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Completed

NCT Number: NCT03390348

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

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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Key information

Conditions

Crying Behavior Communication Fussy Infant (Baby) Nonverbal Communication

Age range

Up to 15 week

Sex eligibility

All sexes

Study type

Observational

Primary location

ObvioHealth

Orlando, Florida, 32826, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LENA Recorder

Device

Use of the LENA recorder to document crying and fussing

Primary outcomes

  1. Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries

    Time frame: 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 outcomes

  1. Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries

    Time frame: 14 days

    Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries

  2. Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder

    Time frame: 14 days

    Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder

Other outcomes

  1. Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface

    Time frame: 14 days

    Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface

  2. Using a parental questionnaire, investigate the usability of the LENA recording device

    Time frame: 14 days

    Using a parental questionnaire, investigate the usability of the LENA recording device

  3. Explore possible correlations between crying and fussing behaviors and infant diet reports

    Time frame: 14 days

    Explore possible correlations between crying and fussing behaviors and infant diet reports

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • LENA Foundation
  • ObvioHealth

Registry information

Acronym: LENUS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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