Status:
NOT_YET_RECRUITING
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Postpartum Depression (PPD)
Self-Efficacy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 w...
Detailed Description
This study is a randomized control trial that will test VoiceLove, a secure mobile app designed to help families communicate with their infants in the Neonatal Intensive Care Unit (NICU). Postpartum ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Infant:
- Admitted to the neonatal intensive care unit (NICU)
- Born at VUMC
- Index admission (NOT a re-admission)
- Born between 23+0 and 31+6 weeks
- Expected to survive at least 2 weeks
- Singleton gestation
- Mother:
- Age ≥ 18 years old
- English speaking
- Mother is the biological mother of the infant admitted to the NICU
- Postpartum day 4 or less
- Partner (NOTE: Partner enrollment is not required)
- Mother agrees to partner's participation
- Designated by mother as support person with infant access
- Exclusion Criteria
- Infant
- a. Re-admission to NICU
- Mother
- No access to an Android or iOS smartphone
- Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
- No personal email address
- Incarcerated at time of delivery or postpartum
- Inability to obtain informed consent
- i. Patient's clinician refuses enrollment of the patient ii. Patient is either mentally (acute psychosis) or physically (intubated or critically ill in the ICU) unable to provide informed consent f. Unable to approach the patient (staffing, patient unavailable) g. Mother is not the intended parent (plans adoption, is a surrogate, will not have custody of the infant)
- Partner (NOTE: Partner enrollment is not required)
- Age \< 18 years old
- Not English speaking
- Inability to obtain informed consent
- No access to an Android or iOS smartphone that is different from the mother's smartphone
- No access to an email address that is different from the mother's email address
- Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07214597
Start Date
December 1 2025
End Date
December 1 2027
Last Update
December 12 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232