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

Vanderbilt University Medical Center · with National Institute of Mental Health (NIMH) · NCT07214597

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
1
Study start
February 4, 2026
Record last updated
June 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: VoiceLove mobile phone application

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Makenna Woods · 615-936-2938 · makenna.woods.1@vumc.org

Study contacts (from the official record)

  • Makenna Woods · 615-936-2938 · makenna.woods.1@vumc.org
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NICU Utilization of Remote Voice Technology to Improve mateRnal… (NCT07214597) | Bored Studies