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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07214597
Status
Recruiting
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Conditions

  • Engagement, Patient
  • Length of Stay
  • Parental Anxiety
  • Postpartum Depression (PPD)
  • Self-Efficacy
  • Usability

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • VoiceLove mobile phone application — DEVICE
    Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.

Study Details

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.

Key Dates

Start date
Feb 4, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Arm
    Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys.
  • No Intervention: Control Arm
    Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app. They will also complete surveys.

Primary Outcome Measure

Patient Engagement with the VoiceLove App [ Time Frame: 2-weeks post randomization. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Makenna Woods
[email protected]
615-936-2938
Sarah Osmundson (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University Medical Center· Nashville, TN

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