Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crying
Fussy Infant (Baby)
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: LENA Foundation
name: ObvioHealth
First posted: 2018-01-04
Enrollment: 12
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term infants of ≤15 weeks of age

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries
timeFrame: 14 days
Secondary outcomes:
measure: Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries
timeFrame: 14 days
measure: Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder
timeFrame: 14 days
Other outcomes:
measure: Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface
timeFrame: 14 days
measure: Using a parental questionnaire, investigate the usability of the LENA recording device
timeFrame: 14 days
measure: Explore possible correlations between crying and fussing behaviors and infant diet reports
timeFrame: 14 days
Locations:
city: Orlando
country: United States
facility: ObvioHealth
state: Florida
Study officials:
affiliation: Obvio Health
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.