NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE) (NCT07214597) | Clinical Trial Compass
RecruitingNot Applicable
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
United States150 participantsStarted 2026-02-04
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Infant:
✓. Admitted to the neonatal intensive care unit (NICU)
✓. Not readmitted after discharge from the NICU
✓. Expected to survive at least 2 weeks
✓. Singleton gestation
✓. Mother:
✓. Age ≥ 18 years old
✓. English speaking
Exclusion criteria
✕. Infant
✕. 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
What they're measuring
1
Patient Engagement with the VoiceLove App
Timeframe: 2-weeks post randomization.
2
Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.