Clinical trial NCT03630679: A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
Official title: A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Healthy
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KK Women's and Children's Hospital
First posted: 2018-08-15
Enrollment: 45
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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
* 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

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Chats on Sleep, Stress and Infant Nutrition
timeFrame: 8 weeks
Secondary outcomes:
measure: Ratings by Parents of Quality of Their Sleep
timeFrame: 8 weeks
measure: Particular Reasons for Stress Caused by the Baby
timeFrame: 8 weeks
measure: Number of Chats on Feedings Among Parents Who Give Their Infants Formula
timeFrame: 8 weeks
Other outcomes:
measure: Satisfaction Scale Scores for Chatbot and ClaimIt
timeFrame: 8 weeks
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Mei Chien Chua, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong J, Foussat AC, Ting S, Acerbi E, van Elburg RM, Mei Chien C. A Chatbot to Engage Parents of Preterm and Term Infants on Parental Stress, Parental Sleep, and Infant Feeding: Usability and Feasibility Study. JMIR Pediatr Parent. 2021 Oct 26;4(4):e30169. doi: 10.2196/30169.