COntact RElationship in Neonatal Intensive Care Unit

NCT06462638 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-05-01

No results posted yet for this study

Summary

The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice.

The study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse.

These behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and/or anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents/nurses who interact with them through voice and touch.

The research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.

Conditions

Interventions

OTHER

Neurobehavioral states and physiological parameters evaluation

Each individual infant included in the study will be assessed 3 times a week for at least two weeks: specifically, two detections of neurobehavioral states in response to interaction with the mother, two detections with the father, and two detections with the nurse(s) will be made. For each infant involved in the study, an audio/video recording of cradle movements and vocalizations will be made at 3 different consecutive times (5 minutes each): baseline; recording during interaction with either parent or nurse; post-interaction assessment. The parent or nurse is asked to interact freely with the baby, choosing whether to use voice and touch or only one of the sensory stimulation channels. During the interactions, parents and nurse will in turn be assessed relative to some basic physiological parameters through the use of a band applied to the chest; the infant's physiological parameters during the 3 times will also be recorded.

OTHER

Maternal vocal pitch evaluation to assess depressive/anxious state

Regarding the assessment of any depressive/anxious states of the mother, as an additional support to the self-report questionnaires the maternal vocal pitch will be specifically assessed through the "Talking about" software (AI algorithm applied to maternal postpartum depression research).

Sponsors & Collaborators

  • Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo

    collaborator UNKNOWN
  • UOC Neonatologia e UTIN, Presidio Ospedaliero G. F. Ingrassia di Palermo

    collaborator UNKNOWN
  • Istituto per la Ricerca e l'Innovazione Biomedica

    lead OTHER

Principal Investigators

  • Gennaro Tartarisco · Istituto per la Ricerca e l'Innovazione Biomedica

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-04-01
Completion
2026-10-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462638 on ClinicalTrials.gov