NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
Recruiting · NCT07214597 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
- Expected to be admitted to the NICU for 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
Where it is running
1 location listed across 1 US state.
- Vanderbilt University Medical Center - Nashville, Tennessee, United States