COntact RElationship in Neonatal Intensive Care Unit (CORE in NICU)

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Enrolling

Conditions: Postpartum Depression; Preterm Birth

Treatments: Other: Maternal vocal pitch evaluation to assess depressive/anxious state; Other: Neurobehavioral states and physiological parameters evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06462638

CNR-IRIB-PRO-2024-007

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 averted and in stable medical condition will be included in the study.
• For parents: Male and female adults aged between 18 and 50 years.

Exclusion criteria

• For infants: Presence of congenital anomalies, neurological disorders, genetic syndromes, and any other condition of developmental atypicality.
• For parents: Parents under 18 years of age; Parents with diagnosed psychiatric disorders and/or sensory disabilities; single parents.

Trial design

80 participants in 1 patient group

Triad - Newborn, mother and father

Description:

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.

Treatment:

Other: Neurobehavioral states and physiological parameters evaluation

Other: Maternal vocal pitch evaluation to assess depressive/anxious state