[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609439":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: VoiceLove mobile phone application",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","VoiceLove mobile phone application","Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.",[9],[26],"VoiceLove app",[28],{"name":29,"affiliation":5,"role":30},"Sarah Osmundson","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Makenna Woods","CONTACT","615-936-2938","makenna.woods.1@vumc.org",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-86.78444,36.16589,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},{"name":29,"role":30,"phone":18,"phoneExt":18,"email":18},{"type":30,"investigatorFullName":29,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Associate Professor in Obstetrics and Gynecology",[57],{"name":58,"class":59},"National Institute of Mental Health (NIMH)","NIH","100609439","nicu-utilization-of-remote-voice-technology-to-improve-maternal-experience-nurture-100609439",false,"NCT07214597","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial","NURTURE","Inclusion Criteria:\n\n1. Infant:\n\n   1. Admitted to the neonatal intensive care unit (NICU)\n   2. Not readmitted after discharge from the NICU\n   3. Expected to survive at least 2 weeks\n   4. Expected to be admitted to the NICU for at least 2 weeks\n   5. Singleton gestation\n2. Mother:\n\n   1. Age ≥ 18 years old\n   2. English speaking\n   3. Mother is the biological mother of the infant admitted to the NICU\n   4. Postpartum day 4 or less\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Mother agrees to partner's participation\n   2. Designated by mother as support person with infant access\n\nExclusion Criteria\n\n1. Infant\n\n   a. Re-admission to NICU\n2. Mother\n\n   1. No access to an Android or iOS smartphone\n   2. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app\n   3. No personal email address\n   4. Incarcerated at time of delivery or postpartum\n   5. Inability to obtain informed consent\n\n   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)\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Age \\\u003C 18 years old\n   2. Not English speaking\n   3. Inability to obtain informed consent\n   4. No access to an Android or iOS smartphone that is different from the mother's smartphone\n   5. No access to an email address that is different from the mother's email address\n   6. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app",true,"FEMALE","18 Years",{"count":72,"type":73},150,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79,80,81,82,83,84],"Postpartum Depression (PPD)","Self-Efficacy","Parental Anxiety","Engagement, Patient","Usability","Length of Stay",[86,87,79,26,66,88],"Neonatal Intensive Care Unit","NICU","VoiceLove","2026-06-15",{"date":91,"type":92},"2026-06-17","ACTUAL",{"date":94,"type":92},"2026-02-04",{"date":96,"type":73},"2028-01",{"name":5,"class":6},1]