NCT Number: NCT06462638
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Observational
Messina, 98164, Italy
Location status: Recruiting
Chiara Ionio
SUB_INVESTIGATOR
Concetta Polizzi
SUB_INVESTIGATOR
Gaspare Cusimano
SUB_INVESTIGATOR
Gennaro Tartarisco
PRINCIPAL_INVESTIGATOR
Serena Iacono Isidoro
CONTACT
Serena Iacono Isidoro
SUB_INVESTIGATOR
Vassilios Fanos
SUB_INVESTIGATOR
Vincenzo Duca
SUB_INVESTIGATOR
Vita Angileri
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: It takes about 20-30 minutes to administer
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.
Time frame: The tool takes approximately 5 minutes to complete
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.
Contact information is provided by the study sponsor or research team.
Gennaro Tartarisco
CONTACT
Maria Valeria Maiorana
CONTACT
Istituto per la Ricerca e l'Innovazione Biomedica
Other
Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)
Acronym: CORE in NICU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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