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

Completed

Conditions studied: Crying, Fussy Infant (Baby)

In brief

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

Key facts

Study ID

NCT03390348

Run by

Danone Asia Pacific Holdings Pte, Ltd.

People needed

12

Starts

2017-11-22

Expected to finish

2018-05-22

Last updated by the study team

2018-08-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• ObvioHealth — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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