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

This study is a randomized control trial that will test VoiceLove, a secure mobile app designed to help families communicate with their infants in the Neonatal Intensive Care Unit (NICU).

Postpartum depression (PPD) is a major depressive disorder and is one of the most frequent childbirth complications. Mother-infant separation during the initial postpartum period, such as infant admission to the neonatal intensive care unit (NICU), impacts mother-infant bonding and increases PPD risk, which is 40% higher in mothers with children admitted to the NICU. The impact of PPD is substantial: reported poor quality of life, high-risk behaviors such as substance abuse or self-harm, and long-term impairments in child cognitive and emotional development. PPD impact on child development has potential to be magnified in the already vulnerable preterm infant population. Care in the NICU is, by design, focused on the health of the infant and ill-equipped to address parental mental health. High stress and burnout among NICU staff combined with limited resources for development of psychosocial programs targeting the parents of NICU patients underscore the need for simple, low-cost, and easily implemented interventions aimed at improving parental connectedness and reducing postpartum mental health disorders.

Lack of parental connectedness to their neonate during a NICU stay and low social support are two of the most powerful risk factors for developing PPD. Risk of PPD is decreased when parents have more contact, either physical or verbal, with their infant and a higher perceived social support system. When physical contact is not possible, voice contact may help foster feelings of connectedness to both the infant in the NICU, and to the parents' social circle. The medical team is another critical source of support poised to increase parental mental health. Mothers of infants in the NICU report increased depressive symptoms when their perception of nurse support is low, while increased communication between parents and the medical team improves parental well-being. Increased social support from loved ones and the medical care team is well positioned to significantly reduce PPD severity in parents of NICU infants. Thus, facilitation of communication between parents and healthcare providers, as well as between their friends and family, presents a low-cost, low effort means to dramatically impact parental mental health and well-being during a NICU admission.

VoiceLove Inc has developed a novel HIPAA-compliant mobile application that offers programmatic support and curated digital content (e.g., lullabies, music, environmental sounds) for infant-family interactions and enables expanded family engagement in hospital settings. VoiceLove mobile app circumvents barriers to communication through an electronic venue for direct patient-family-clinician interaction. Specifically for clinicians, VoiceLove is a safe and time-efficient tool for direct communication with absent family members, allowing more time for direct patient care.

• EPDS Score at 6-weeks post randomization [Time frame: 6-weeks post randomization.]
• Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks. [Time frame: 2- and 6-weeks post randomization]
• PROMIS Informational Support at 2- and 6-weeks post randomization [Time frame: 2- and 6-weeks post randomization]
• PROMIS Self-Efficacy at 2- and 6-weeks post randomization [Time frame: 2- and 6-weeks post randomization]
• Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization [Time frame: 2- and 6-weeks post randomization]
• Post Traumatic Stress Disorder Checklist (PCL-5) at NICU discharge [Time frame: at infant's NICU discharge, up to six (6) months.]
• NICU length of stay [Time frame: from NICU admission to NICU discharge, up to six (6) months.]
• Infant birth weight at NICU discharge [Time frame: from NICU admission to NICU discharge, up to six (6) months.]
• App Usability and Satisfaction Scale at 2- and 6-weeks post randomization [Time frame: 2- and 6-weeks post randomization]