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

Crying Clinical Trial

— LENUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390348
• Other study ID #: OBVIO-DAN-001
• Secondary ID: EBB17GC16811
• Status: Completed
• Start date: November 22, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: August 2018
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Crying
• Fussy Infant (Baby)

Intervention

Device:
• LENA Recorder
Use of the LENA recorder to document crying and fussing

Locations

Country	Name	City	State
United States	ObvioHealth	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	LENA Foundation, ObvioHealth

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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