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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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. 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
Study sites (1)
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Makenna Woods · Study contact · 615-936-2938 · makenna.woods.1@vumc.orgSarah Osmundson · Principal investigatorMore trials in Nashville