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| Name | Class |
|---|---|
| KK Women's and Children's Hospital | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm | born at <37 weeks of gestation | ||
| Full term Term | born at >/= 37 weeks of gestation |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Scale Scores for Chatbot and ClaimIt | Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire | 8 weeks |
Inclusion Criteria:
Subjects (parent and infant) must meet the following criteria:
Exclusion Criteria:
Infant must not meet any of the following criteria:
Parent must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mei Chien Chua, MBBS | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34544679 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preterm | born at <37 weeks of gestation |
| FG001 | Full Term Term | born at >/= 37 weeks of gestation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preterm | born at <37 weeks of gestation |
| BG001 | Full Term Term | born at >/= 37 weeks of gestation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Chats | 8 weeks |
|
|
duration of the study - 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preterm | born at <37 weeks of gestation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Digital Project Manager | Danone Asia Pacific Holdings | 82281172 | jill.wong@danone.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2018 | Mar 13, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2019 | Mar 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | 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 | Per Protocol | Posted | Number | chat responses | 8 weeks |
|
|
|
| Secondary | 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 | Per Protocol | Posted | Number | chat responses | 8 weeks |
|
|
|
| Secondary | 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 | Per Protocol | Posted | Number | chat responses | 8 weeks |
|
|
|
| Other Pre-specified | Satisfaction Scale Scores for Chatbot and ClaimIt | Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire | Per Protocol | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Full Term Term | born at >/= 37 weeks of gestation | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |
| 3 (Bad) |
|
| 4 (Very Bad) |
|
| My baby's feeding habits |
|
| My baby's growth |
|
| My baby's sleeping patterns |
|
| Other |
|
| 8 to 11 |
|
| 12 and above |
|