NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)

NCT07214597 | Recruiting FDA Device

• 2 other identifiers: 2514614R42MH135602-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Self-Efficacy; Parental Anxiety; Engagement, Patient; Usability; Length of Stay; Postpartum Depression (PPD)

Keywords

Neonatal Intensive Care Unit; NICU; Postpartum Depression (PPD); VoiceLove app; NURTURE; VoiceLove

Outcome Measures

Primary Outcomes (2)

• Patient Engagement with the VoiceLove App

  To assess the feasibility of using the VoiceLove app, we will measure how much patients in the intervention group engage with the app using metrics such as average app use per day at 2-weeks post randomization.

  2-weeks post randomization.

• Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.

  The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.

  2-weeks post randomization.

Secondary Outcomes (9)

• EPDS Score at 6-weeks post randomization

  6-weeks post randomization.

• Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.

  2- and 6-weeks post randomization

• PROMIS Informational Support at 2- and 6-weeks post randomization

  2- and 6-weeks post randomization

• PROMIS Self-Efficacy at 2- and 6-weeks post randomization

  2- and 6-weeks post randomization

• Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization

  2- and 6-weeks post randomization

Other Outcomes (4)

• Clinically meaningful infant outcomes

  From randomization through discharge, up to 6 months.

• Infant short-term outcomes

  From randomization through discharge, up to 6 months.

• Infant short-term outcomes

  From randomization through discharge, up to 6 months.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys.

Device: VoiceLove mobile phone application

Control Arm

NO INTERVENTION

Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app. They will also complete surveys.

Interventions

VoiceLove mobile phone application DEVICE

Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.

Also known as: VoiceLove app

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Patient Participation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sarah Osmundson

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makenna Woods

CONTACT

615-936-2938; makenna.woods.1@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Obstetrics and Gynecology

Model Details: Infant/mother dyads will be randomized in a 1:1 ratio stratified by infant gestational age at delivery (\<28 vs ≥28 weeks) and depression/anxiety diagnosis of the mother (measured by baseline EPDS ≥13). Gestational age is strongly associated with infant length of NICU stay. To reduce the risk of selection bias, we will use allocation concealment employing a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the biostatistician creating the randomization list and will not be shared with investigators or any other study personnel. This list will be directly uploaded into REDCap's randomization module. Treatment assignment will be known by study participants, research personnel, and medical team given the unblinded nature of the intervention. Randomization procedure details, including stratification and block sizes, will be reported in trial publications. Randomization assignments are accessible 27/4.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 9, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)