Preterm BirthNCT03630679
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
An observational study of Preterm Birth and Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Healthy
- How many people
- 45 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Nov 2018to 9 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * 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 * 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants
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.
Read the 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
- Conditions
- Preterm Birth, Healthy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm | born at <37 weeks of gestation | |
| Full term Term | born at >/= 37 weeks of gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start7 Nov 2018
- Primary completion1 Mar 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KK Women's and Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Mei Chien Chua, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630679
- Sponsor's protocol ID
- OBVIO-DAN-003
- Status last verified
- Aug 2020
- First submitted
- 17 Jul 2018
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34544679
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants
- ClinicalTrials.gov ID
- NCT03630679
- Acronym / sponsor ID
- OBVIO-DAN-003
- Conditions
- Preterm Birth, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KK Women's and Children's Hospital
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm | – | –born at <37 weeks of gestation |
| Full term Term | – | –born at >/= 37 weeks of gestation |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * 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 * 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Chats on Sleep, Stress and Infant Nutrition
Time frame: 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
3 secondary outcomes
Ratings by Parents of Quality of Their Sleep
Time frame: 8 weeks
Particular Reasons for Stress Caused by the Baby
Time frame: 8 weeks
Number of Chats on Feedings Among Parents Who Give Their Infants Formula
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34544679Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Chien Chua, MBBS principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Chats on Sleep, Stress and Infant Nutrition (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.