COntact RElationship in Neonatal Intensive Care Unit

Last updated: April 29, 2025
Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

Neurobehavioral states and physiological parameters evaluation

Maternal vocal pitch evaluation to assess depressive/anxious state

Clinical Study ID

NCT06462638
CNR-IRIB-PRO-2024-007
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For infants: Infants with gestational age between 33 and 36 weeks, weighing around 2kg (LBW - low birth weight), in whom life-threatening conditions have been avertedand in stable medical condition will be included in the study.

  • For parents: Male and female adults aged between 18 and 50 years.

Exclusion

Exclusion Criteria:

  • For infants: Presence of congenital anomalies, neurological disorders, geneticsyndromes, and any other condition of developmental atypicality.

  • For parents: Parents under 18 years of age; Parents with diagnosed psychiatricdisorders and/or sensory disabilities; single parents.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Neurobehavioral states and physiological parameters evaluation
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

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

    Messina, 98164
    Italy

    Active - Recruiting

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