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ID06462638

Study of Physical and Vocal Contact Effects on Development in Preterm Infants and Their Caregivers in the NICU

Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2025-05-01

80

Participants Needed

1

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring how contact, especially through voice and touch, between caregivers and moderately preterm infants in the Neonatal Intensive Care Unit NICU can support the infants developmental and maturational processes. The study focuses on comparing the effects of the maternal voice, paternal voice, and a familiar non-parental voice, such as a NICU nurses, on the infants neurobehavioral states. It also considers the psychological condition of the parents, such as postpartum depression and anxiety, which may influence infant responses and parent-infant interactions. The study involves triads of mother, father, and moderately preterm infants born between 33 and 36 weeks gestation, who are medically stable and admitted to the NICU. Each infant will be assessed multiple times weekly over at least two weeks through audiovideo recordings during interactions with each caregiver and the nurse. These interactions allow free use of voice and touch, while physiological parameters of both infants and adults are monitored with wearable devices. Additionally, maternal vocal pitch will be analyzed with artificial intelligence software to help detect postpartum depression alongside standard questionnaires. Participants will engage in assessments including the Neonatal Behavioural Assessment Scale NBAS and the Edinburgh Postnatal Depression Scale EPDS. The study collects behavioral, neurophysiological, and psychological data to better understand early parent-infant communication and support. The involvement includes repeated observational sessions, questionnaire completion, and physiological monitoring. The research aims to improve support for parents and healthcare staff during the NICU hospitalization period, with the study planned through October 2026.

CONDITIONS

Brief Title

COntact RElationship in Neonatal Intensive Care Unit

Research Team

G

Gennaro Tartarisco

M

Maria Valeria Maiorana

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