Voice app to help NICU mothers connect with their babies (NURTURE)
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial
This trial will test whether the VoiceLove mobile app helps mothers with infants in the NICU have less postpartum depression compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07214597 on ClinicalTrials.gov |
What this trial studies
This is a Phase II randomized controlled trial comparing the VoiceLove mobile app to usual care for mothers whose infants are admitted to the Neonatal Intensive Care Unit. The primary outcome is maternal postpartum depression measured by the Edinburgh Postnatal Depression Scale (EPDS), and secondary outcomes include feasibility, acceptability, patterns of communication and engagement, and infant length of stay. Data sources will include app usage metrics, satisfaction surveys, and qualitative interviews with mothers, partners (optional), and NICU clinicians. Estimates from this trial will inform a future definitive Phase III trial.
Who should consider this trial
Good fit: Ideal candidates are English-speaking biological mothers aged 18 or older whose singleton infant is admitted to the NICU within 4 days postpartum, expected to survive at least two weeks, and who have an iOS or Android smartphone.
Not a fit: Patients without a smartphone, non-English speakers, incarcerated persons, those unable to consent, or mothers of infants who do not meet the infant inclusion criteria are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could reduce postpartum depression symptoms and strengthen mother–infant bonding during a NICU stay.
How similar studies have performed: Mobile interventions for perinatal mental health have shown promise in prior work, but a voice-recording and NICU-specific app like VoiceLove is a relatively novel approach with limited prior trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 2. Mother 1. No access to an Android or iOS smartphone 2. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app 3. No personal email address 4. Incarcerated at time of delivery or postpartum 5. 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) 3. Partner (NOTE: Partner enrollment is not required) 1. Age \< 18 years old 2. Not English speaking 3. Inability to obtain informed consent 4. No access to an Android or iOS smartphone that is different from the mother's smartphone 5. No access to an email address that is different from the mother's email address 6. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Osmundson — Vanderbilt University Medical Center
- Study coordinator: Makenna Woods
- Email: makenna.woods.1@vumc.org
- Phone: 615-936-2938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.