Skip to main content
OpenTrials
Completed

NCT Number: NCT03630679

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Healthy Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hospital

Singapore

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Ratings by Parents of Quality of Their Sleep

    Time frame: 8 weeks

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

  2. Particular Reasons for Stress Caused by the Baby

    Time frame: 8 weeks

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

  3. Number of Chats on Feedings Among Parents Who Give Their Infants Formula

    Time frame: 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 outcomes

  1. Satisfaction Scale Scores for Chatbot and ClaimIt

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • KK Women's and Children's Hospital

Registry information

Official study title

A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.