Healthy, Preterm Birth
Conditions
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
Interventions
None listed
Sponsors
KK Women's and Children's Hospital
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Chats on Sleep, Stress and Infant Nutrition | 8 weeks | Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratings by Parents of Quality of Their Sleep | 8 weeks | Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants |
| Particular Reasons for Stress Caused by the Baby | 8 weeks | Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants |
| Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 8 weeks | Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Scale Scores for Chatbot and ClaimIt | 8 weeks | 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 |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preterm born at \<37 weeks of gestation | 20 |
| Full Term Term born at \>/= 37 weeks of gestation | 25 |
| Total | 45 |
Baseline characteristics
| Characteristic | Preterm | Full Term Term | Total |
|---|---|---|---|
| Age, Customized Parent's age 21-25 years old | 2 Participants | 1 Participants | 3 Participants |
| Age, Customized Parent's age 26-30 years old | 3 Participants | 10 Participants | 13 Participants |
| Age, Customized Parent's age 31-35 years old | 10 Participants | 8 Participants | 18 Participants |
| Age, Customized Parent's age 36-40 years old | 4 Participants | 6 Participants | 10 Participants |
| Age, Customized Parent's age 41-45 years old | 1 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Singapore | 20 participants | 25 participants | 45 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 25 |
| other Total, other adverse events | 0 / 20 | 0 / 25 |
| serious Total, serious adverse events | 0 / 20 | 0 / 25 |
Outcome results
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
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm | Number of Chats on Sleep, Stress and Infant Nutrition | 131 Chats |
| Full Term Term | Number of Chats on Sleep, Stress and Infant Nutrition | 125 Chats |
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
Time frame: 8 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 0 to 3 | 19 chat responses |
| Preterm | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 4 to 7 | 30 chat responses |
| Preterm | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 8 to 11 | 22 chat responses |
| Preterm | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 12 and above | 1 chat responses |
| Full Term Term | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 12 and above | 1 chat responses |
| Full Term Term | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 0 to 3 | 13 chat responses |
| Full Term Term | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 8 to 11 | 13 chat responses |
| Full Term Term | Number of Chats on Feedings Among Parents Who Give Their Infants Formula | 4 to 7 | 19 chat responses |
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
Time frame: 8 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm | Particular Reasons for Stress Caused by the Baby | My baby is crying a lot | 0 chat responses |
| Preterm | Particular Reasons for Stress Caused by the Baby | My baby is sick | 4 chat responses |
| Preterm | Particular Reasons for Stress Caused by the Baby | My baby's feeding habits | 3 chat responses |
| Preterm | Particular Reasons for Stress Caused by the Baby | My baby's growth | 1 chat responses |
| Preterm | Particular Reasons for Stress Caused by the Baby | My baby's sleeping patterns | 0 chat responses |
| Preterm | Particular Reasons for Stress Caused by the Baby | Other | 9 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | My baby's sleeping patterns | 1 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | My baby is crying a lot | 3 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | My baby's growth | 1 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | My baby is sick | 0 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | Other | 0 chat responses |
| Full Term Term | Particular Reasons for Stress Caused by the Baby | My baby's feeding habits | 3 chat responses |
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
Time frame: 8 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm | Ratings by Parents of Quality of Their Sleep | 1 (Very Good) | 20 chat responses |
| Preterm | Ratings by Parents of Quality of Their Sleep | 2 (Good) | 42 chat responses |
| Preterm | Ratings by Parents of Quality of Their Sleep | 3 (Bad) | 55 chat responses |
| Preterm | Ratings by Parents of Quality of Their Sleep | 4 (Very Bad) | 5 chat responses |
| Full Term Term | Ratings by Parents of Quality of Their Sleep | 4 (Very Bad) | 7 chat responses |
| Full Term Term | Ratings by Parents of Quality of Their Sleep | 1 (Very Good) | 13 chat responses |
| Full Term Term | Ratings by Parents of Quality of Their Sleep | 3 (Bad) | 38 chat responses |
| Full Term Term | Ratings by Parents of Quality of Their Sleep | 2 (Good) | 48 chat responses |
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
Time frame: 8 weeks
Population: Per Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preterm | Satisfaction Scale Scores for Chatbot and ClaimIt | ClaimIt Satisfaction | 3.69 score on a scale | Standard Deviation 0.85 |
| Preterm | Satisfaction Scale Scores for Chatbot and ClaimIt | Chatbot Satisfaction | 3.62 score on a scale | Standard Deviation 0.96 |
| Full Term Term | Satisfaction Scale Scores for Chatbot and ClaimIt | Chatbot Satisfaction | 4.0 score on a scale | Standard Deviation 0.82 |
| Full Term Term | Satisfaction Scale Scores for Chatbot and ClaimIt | ClaimIt Satisfaction | 3.92 score on a scale | Standard Deviation 0.76 |