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NCT05853666
Connecting Families to Improve Parental Self-efficacy and Parent Psychosocial and Infant Health Outcomes in the NICU
Conditions: Self Efficacy, Infant Development, eHealth, Mental Health Wellness 1
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 600
Sponsor: IWK Health Centre
Location: IWK Health Halifax Nova Scotia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05853666). StuddyBuddy aggregates publicly available trial information.