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)

Danone

Status: Completed

Conditions: Crying; Fussy Infant (Baby)

Treatments: Device: LENA Recorder

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03390348

OBVIO-DAN-001

EBB17GC16811 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: Under 15 weeks old

Volunteers: Accepts Healthy Volunteers

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