MedPath

A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot

Completed
Conditions
Preterm Birth
Healthy
Registration Number
NCT03630679
Lead Sponsor
Danone Asia Pacific Holdings Pte, Ltd.
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 β‰₯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 β‰₯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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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 β‰₯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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Chats on Sleep, Stress and Infant Nutrition8 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 Outcome Measures
NameTimeMethod
Particular Reasons for Stress Caused by the Baby8 weeks

Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants

Ratings by Parents of Quality of Their Sleep8 weeks

Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants

Number of Chats on Feedings Among Parents Who Give Their Infants Formula8 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

Trial Locations

Locations (1)

KK Women's and Children's Hospital

πŸ‡ΈπŸ‡¬

Singapore, Singapore

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