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

Study Overview
=================
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

Official Title
-----------------
A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants

Conditions
-----------------
Preterm Birth, Healthy

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm<br>born at <37 weeks of gestation | |
| Full term Term<br>born at >/= 37 weeks of gestation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Chats on Sleep, Stress and Infant Nutrition | Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings by Parents of Quality of Their Sleep | Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants | 8 weeks | 
| Particular Reasons for Stress Caused by the Baby | Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants | 8 weeks | 
| Number of Chats on Feedings Among Parents Who Give Their Infants Formula | Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula | 8 weeks |