NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial
Vanderbilt University Medical Center
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.
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 depression (PPD) is a major depressive disorder and is one of the most frequent childbirth complications. Mother-infant separation during the initial postpartum period, such as infant admission to the neonatal intensive care unit (NICU), impacts mother-infant bonding and increases PPD risk, which is 40% higher in mothers with children admitted to the NICU. The impact of PPD is substantial: reporte…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Infant: 1. Admitted to the neonatal intensive care unit (NICU) 2. Not readmitted after discharge from the NICU 3. Expected to survive at least 2 weeks 4. Singleton gestation 2. Mother: 1. Age ≥ 18 years old 2. English speaking 3. Mother is the biological mother of the infant admitted to the NICU 4. Postpartum day 4 or less 3. Partner (NOTE: Partner enrollment is not required) 1. Mother agrees to partner's participation 2. Designated by mother as support person with infant access Exclusion Criteria 1. Infant a. Re-admission to NICU…
Interventions
- DeviceVoiceLove mobile phone application
Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.
Location
- Vanderbilt University Medical CenterNashville, Tennessee