Actively Recruiting
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
Led by Vanderbilt University Medical Center · Updated on 2026-04-20
150
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant admitted to the neonatal intensive care unit (NICU)
- Infant not readmitted after NICU discharge
- Infant expected to survive at least 2 weeks
- Infant from a singleton pregnancy
- Mother aged 18 years or older
- Mother speaks English
- Mother is the biological mother of the NICU infant
- Mother is within 4 days postpartum
- Mother agrees to partner participation if applicable
- Partner designated by mother as support person with infant access (partner enrollment optional)
You will not qualify if you...
- Infant has been readmitted to the NICU
- Mother does not have access to an Android or iOS smartphone
- Mother unwilling to download the VoiceLove NICU app or accept its terms
- Mother has no personal email address
- Mother is incarcerated at delivery or postpartum
- Mother unable to provide informed consent due to clinician refusal, mental or physical incapacity, or unavailability
- Mother is not the intended parent (plans adoption, surrogate, or no custody of infant)
- Partner under 18 years old
- Partner does not speak English
- Partner unable to provide informed consent
- Partner lacks separate smartphone or email from mother
- Partner unwilling to download the VoiceLove NICU app or accept its terms
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Makenna Woods
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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