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 | Completed

• 2 other identifiers: OBVIO-DAN-001EBB17GC16811
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Crying; Fussy Infant (Baby)

Outcome Measures

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

  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 Outcomes (2)

• 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

  14 days

Other Outcomes (3)

• 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

  14 days

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

  14 days

Interventions

LENA Recorder DEVICE

Use of the LENA recorder to document crying and fussing

Eligibility Criteria

• Age: Up to 15 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy term infants of ≤15 weeks of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• LENA Foundation: collaborator
• ObvioHealth: collaborator

Study Sites (1)

ObvioHealth

Orlando, Florida, 32826, United States

Location

Related Publications (2)

• 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.

  PMID: 22751753 BACKGROUND

• 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.

  PMID: 26174716 RESULT

MeSH Terms

Conditions

Crying

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Officials

• Parth Shah, MD

  Obvio Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 4, 2018
• Study Start: November 22, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)