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

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

Study Overview

• Status: Completed
• Conditions: Crying; Fussy Infant (Baby)
• Intervention / Treatment: Device: LENA Recorder

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32826
      • ObvioHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy term infants of ≤15 weeks of age

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries	Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries	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 detected by the LENA recorder	Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface	Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface	14 days
Using a parental questionnaire, investigate the usability of the LENA recording device	Using a parental questionnaire, investigate the usability of the LENA recording device	14 days
Explore possible correlations between crying and fussing behaviors and infant diet reports	Explore possible correlations between crying and fussing behaviors and infant diet reports	14 days

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: ObvioHealth; LENA Foundation
• Investigators: Principal Investigator: Parth Shah, MD, Obvio Health

Publications and helpful links

General Publications

• Dykstra JR, Sabatos-Devito MG, Irvin DW, Boyd BA, Hume KA, Odom SL. Using the Language Environment Analysis (LENA) system in preschool classrooms with children with autism spectrum disorders. Autism. 2013 Sep;17(5):582-94. doi: 10.1177/1362361312446206. Epub 2012 Jul 2.
• Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2017
• Primary Completion (ACTUAL): May 22, 2018
• Study Completion (ACTUAL): May 22, 2018

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OBVIO-DAN-001; EBB17GC16811 (OTHER: DAPH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No