RecruitingNot ApplicableNCT07214597

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

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


Sponsor

Vanderbilt University Medical Center

Enrollment

150 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called NURTURE) is testing whether a voice messaging app called VoiceLove NICU can help mothers of premature babies feel more connected to their babies while they are in the neonatal intensive care unit (NICU). Mothers and their support partners can record and send voice messages to their babies. **You may be eligible if...** - Your baby was born between 23 and 31 weeks of pregnancy and is admitted to the NICU at Vanderbilt University Medical Center - You are the biological mother, age 18 or older, and it is within 4 days of delivery - You speak English and have a smartphone capable of downloading the app **You may NOT be eligible if...** - Your baby was previously admitted to the NICU (re-admission) - You do not have a smartphone or are unwilling to download the app - You are incarcerated, cannot provide consent, or are not the intended parent (e.g., surrogate) - You do not have a personal email address Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVoiceLove mobile phone application

Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07214597


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