N/A
Completed N=45
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
Preterm Birth · Healthy
Source: ClinicalTrials.gov NCT03630679 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Chats on Sleep, Stress and Infant Nutrition — 131; 125 Chats
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Chats on Sleep, Stress and Infant Nutrition |
131; 125 | — |
| SECONDARY Ratings by Parents of Quality of Their Sleep |
20; 13; 42; 48; 55; 38 | — |
| SECONDARY Particular Reasons for Stress Caused by the Baby |
0; 3; 4; 0; 3; 3 | — |
| SECONDARY Number of Chats on Feedings Among Parents Who Give Their Infants Formula |
19; 13; 30; 19; 22; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT03630679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.