A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot

Danone

Status: Completed

Conditions: Healthy; Preterm Birth

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03630679

OBVIO-DAN-003

Details and patient eligibility

About

20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Full description

20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.

Data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared.

An evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted

Enrollment: 45 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects (parent and infant) must meet the following criteria:

• Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment
• Infants must be at home (discharged from the hospital) at time of enrollment
• Informed consent from parent whose age is ≥21 years
• Parent must be proficient in the English language
• Parent must be able to comply with the required study tasks, as per PI's judgment
• In-home access to reliable internet connections; a mobile device suitable for electronic communication

Exclusion criteria

Infant must not meet any of the following criteria:

• Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)
• Must not be currently participating in any other clinical study

Parent must not meet any of the following criteria:

• Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:
• Presence of current mental illness or history of mental illness
• Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment
• Must not be a single parent
• Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements

Trial design

45 participants in 2 patient groups

Preterm

Description:

born at <37 weeks of gestation

Full term Term

Description:

born at >/= 37 weeks of gestation