COntact RElationship in Neonatal Intensive Care Unit
NCT Number: NCT06462638
Acronym: CORE in NICU
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Preterm Birth|Postpartum Depression
Interventions: OTHER: Neurobehavioral states and physiological parameters evaluation|OTHER: Maternal vocal pitch evaluation to assess depressive/anxious state
Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators: Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo|UOC Neonatologia e UTIN, Presidio Ospedaliero G. F. Ingrassia di Palermo
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-10-31
Locations: Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy, Messina, 98164, Italy

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.

Primary Outcome Measures: Neonatal Behavioural Assessment Scale (NBAS), The NBAS is best described as a neurobehavioral assessment scale, designed to describe the newborn's behavioral responses to his/her new extrauterine environment and to document the contribution of the newborn infant to the development of the emerging parent-child relationship. It assesses the newborn's behavioral repertoire with 28 behavioral items, each scored on a 9-point scale. It also includes an assessment of the infant's neurological status on 20 items, each scored on a 4-point scale. It is used to examine the effects of prematurity, low birthweight, undernutrition and a range of pre-and perinatal risk factors, the effects of prenatal substance exposure. The exam does not yield a single score but instead assesses the baby's capabilities across different developmental areas and describes how the baby integrates these areas as s/he deals with her/his new environment., It takes about 20-30 minutes to administer|Edinburgh Postnatal Depression Scale (EPDS), The EPDS is the most widely used tool for the screening of perinatal affective disorders during the transition to parenthood. It consists of 10 questions related to various symptoms of depression. The questions on the EPDS focus on depressed mood, anxiety and anhedonia. The EPDS has been constructed to assess depressive symptoms in postpartum women, but it can be used to make extremely fast screening in men who are experiencing the transition to parenthood.

The response format is a 4-point Likert scale (0 to 3), with an overall score between 0 and 30. A total score of greater than 10 indicates possible depression for mothers, whereas the optimal cutoff for fathers is 12/13., The tool takes approximately 5 minutes to complete