COntact RElationship in Neonatal Intensive Care Unit

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Study ID
NCT06462638
Status
Recruiting
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Conditions

  • Postpartum Depression
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Neurobehavioral states and physiological parameters evaluation — OTHER
    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.
  • Maternal vocal pitch evaluation to assess depressive/anxious state — OTHER
    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).

Study Details

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.

Key Dates

First listed
Jun 17, 2024
Start date
Nov 1, 2024
Status verified
Apr 2025
Primary completion
Apr 1, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Triad - Newborn, mother and father
    The study involves triads of mother, father, moderately/late preterm born infant, admitted to the NICU. The population of moderately preterm infants admitted to a Neonatal Intensive Care Unit (NICU) and their parents are individuals who face a unique and complex set of challenges. These infants are at a stage when many of their organs and body systems are not yet fully developed. This incomplete development makes them particularly vulnerable to various medical complications. As for the parents of these infants, the experience of having a baby admitted to the NICU is often a source of great emotional and psychological stress. Preterm birth, which is generally unexpected, can generate feelings of anxiety, fear and uncertainty about their baby's short- and long-term health. They need clear and understandable informational support to help them feel more involved and less helpless in their baby's care.

Primary Outcome Measure

Neonatal Behavioural Assessment Scale (NBAS) [ Time Frame: It takes about 20-30 minutes to administer ]

Central Contacts

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