NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the preliminary effectiveness of the VoiceLove app in reducing maternal postpartum depression among mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). This Phase II randomized controlled trial aims to compare VoiceLove with usual care and will provide data for a future Phase III trial. The study also examines how the app affects communication patterns between mothers, partners, and NICU clinicians, as well as the infant's length of stay in the NICU. Participants are randomly assigned to one of two groups: one group receives access to the VoiceLove mobile app along with standard care and surveys, while the other group receives standard care only and completes surveys without app access. VoiceLove is a secure, HIPAA-compliant mobile application designed to facilitate communication between family members and NICU patients through curated digital content and real-time messaging. The study focuses on the initial weeks following randomization, with follow-up assessments at 2 and 6 weeks, and monitoring infant outcomes up to 6 months. Mothers who participate will complete surveys measuring postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) at 2 and 6 weeks after enrollment. Additional assessments include measures of anxiety, self-efficacy, social support, and app usability. Researchers will also track app usage, satisfaction, and infant health outcomes such as birth weight and NICU length of stay. The total study participation lasts through the infant's NICU stay and follow-up periods, with ongoing monitoring for up to 6 months to assess the app's impact and feasibility.

NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)