A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot (NCT03630679) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
Singapore45 participantsStarted 2018-11-07
Plain-language 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.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Chats on Sleep, Stress and Infant Nutrition