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

RecruitingNAAges 18 Years - anyFemaleVanderbilt University Medical Center
NCT07214597 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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. Expected to be admitted to the NICU for at least 2 weeks 5. 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
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What it tests

  • VoiceLove mobile phone application
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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