Clinical Trial

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

Study acronym: NURTURE
Recruiting
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Summary
The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-10-07; most recent amendment 2026-06-15.
Status change: Not Yet Recruiting → Recruiting 2026-02-09
Trial Details
NCT Number NCT07214597
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute of Mental Health (NIMH)
Conditions Postpartum Depression (PPD), Self-Efficacy, Parental Anxiety, Engagement, Patient, Usability, Length of Stay
Enrollment 150 participants
Start Date 2026-02-04
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-17