Recruiting

Chez NICU Home+

Sponsor:

IWK Health Centre

Code:

NCT05853666

Conditions

Self Efficacy

Infant Development

eHealth

Mental Health Wellness 1

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

CNH+

Study Details

Brief summary:

Preterm infants, 1 in 12 Canadian births, are at a significant increased risk of poor health outcomes, resulting in high healthcare burden. Parents of these infants report lower self-efficacy and worse mental health when compared to parents of term infants. There is an urgent need to use effective ways to improve parental self-efficacy and associated parent psychosocial and infant health outcomes. To improve parent and baby outcomes, the investigators will build on an existing eHealth solution to create Chez NICU Home+ (CNH+), which offers web-based, parent-targeted, interactive educational tools, virtual communication, and text message support during a baby's NICU stay. We will evaluate whether Chez NICU Home+ improves parental self-efficacy (primary outcome), parent psychosocial, and infant health outcomes in parents of babies requiring a NICU stay, and the implementation (ease and uptake) of Chez NICU Home+ in multiple sites. This study will be a multicentre implementation study, with a stepped wedge cluster randomized controlled trial across four Canadian NICUs. At the beginning of the study, data regarding current care will be collected from all sites to determine a baseline. Following baseline data collection, every five months one of the sites will start using the Chez NICU Home+ solution. A total of 600 parents and their babies, who are expected to stay at least 14 days in the NICU, will be recruited. Parents will complete a survey on psychosocial adjustment and infant outcomes when the study begins, as well as at 14 and 21 days after enrollment, at infant discharge from the NICU, and at 6 months post-discharge. Infant health and development outcomes will be collected at discharge, 6 and 18 months post-discharge via health records. The investigators predict that Chez NICU Home+ will be a positive, interactive care option, combining virtual parent education, tailored communication, and support, which will improve parental self-efficacy and parent psychosocial and infant health outcomes, and have long-term benefits for families.

Conditions

Self Efficacy

Infant Development

eHealth

Mental Health Wellness 1

Study ID

NCT05853666

Start date

Sep 8, 2023

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Parents who have an infant admitted to the NICU
  • Parents who provide consent to participate within 7 days following birth
  • Infant (regardless of gestational age or diagnosis) is anticipated to have at least a 14-day NICU stay

Exclusion Criteria:

  • Parents who are unable to read or write English
  • Parents whose infant is not anticipated to survive within the 7-day enrollment period after birth based on attending physician assessment

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Group with Standard Care

Consenting families in the NICU during the baseline control period will receive standard care as it is already provided at each site. Data collection procedures will mirror intervention groups to ensure comparable control data.

experimental: Intervention Group Receiving CNH+

Eligible consenting families (following enrollment) will be provided a secure login code and instructions to access the CNH+ educational modules and to send and receive virtual calls and text messages. Parents will be asked to use CNH+ during their entire NICU stay. To ensure equity, interested families without a personal device to access CNH+ will be offered a study-provided iPad for the duration of their infant's stay. Parents will have access to CNH+ while on the unit and 6 months post-discharge.

Interventions

CNH+

CNH+ is a bundled intervention targeting all four of Bandura's factors associated with improved self-efficacy (i.e., Mastery \[evidence-based parent targeted education platform\]; Vicarious Experience \[observing other families similar to them succeeding in a task i.e., videos and photos\]; Verbal Persuasion \[in-person/virtual medical rounds and provision of social support\]; and Physiological States \[notifications and encouragement through mHealth text messaging, parent feedback, and tailored clinical care pathway\]).

Primary outcome measure

  • Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at infant discharge date (immediately after the infant is discharged from the NICU) [ Time Frame: At baseline and immediately after the infant is discharged from the NICU (the end of in-hospital phase) ]
  • Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 21 days (after the infant is born) [ Time Frame: At baseline, discharge to another unit (if eligible), and 21 days after the infant is born ]
  • Change from baseline parental self-perceived self-efficacy (as measured by the Perceived Maternal Parenting Self-Efficacy tool) at 6 months (after the infant is discharged from the NICU) [ Time Frame: At baseline and 6 months after the infant is discharged from the NICU ]

Central Contacts and Locations

Central contacts

Locations

IWK Health

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

More Information

Sponsor

IWK Health Centre

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • Neonatal
  • Parents
  • Families
  • eHealth
  • Implementation
  • Parent mental health
  • Infant outcomes
  • Parent presence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.