Voice app to help NICU mothers connect with their babies (NURTURE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II randomized controlled trial comparing the VoiceLove mobile app to usual care for mothers whose infants are admitted to the Neonatal Intensive Care Unit. The primary outcome is maternal postpartum depression measured by the Edinburgh Postnatal Depression Scale (EPDS), and secondary outcomes include feasibility, acceptability, patterns of communication and engagement, and infant length of stay. Data sources will include app usage metrics, satisfaction surveys, and qualitative interviews with mothers, partners (optional), and NICU clinicians. Estimates from this trial will inform a future definitive Phase III trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Sarah Osmundson — Vanderbilt University Medical Center
• Study coordinator: Makenna Woods
• Email: makenna.woods.1@vumc.org
• Phone: 615-936-2938

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.