Actively Recruiting

Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06462638

COntact RElationship in Neonatal Intensive Care Unit

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

80

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

I

Istituto per la Ricerca e l'Innovazione Biomedica

Lead Sponsor

S

Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

COntact RElationship in Neonatal Intensive Care Unit

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born between 33 and 36 weeks of gestational age, weighing around 2kg, medically stable without life-threatening conditions
  • Adults aged 18 to 50 years who are parents of the infant
Not Eligible

You will not qualify if you...

  • Infants with congenital anomalies, neurological disorders, genetic syndromes, or developmental atypicalities
  • Parents under 18 years old
  • Parents diagnosed with psychiatric disorders or sensory disabilities
  • Single parents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy

Messina, Italy, 98164

Actively Recruiting

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Research Team

G

Gennaro Tartarisco

CONTACT

M

Maria Valeria Maiorana

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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