COntact RElationship in Neonatal Intensive Care Unit

Официальное название

Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Neonatal Behavioural Assessment Scale (NBAS) [Срок оценки: It takes about 20-30 minutes to administer]
• Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: The tool takes approximately 5 minutes to complete]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

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

Публикации

• Egmose I, Vaever MS, Smith-Nielsen J, Varni G, Koppe S. Motor activity and spatial proximity: Relationships to infant emotions and maternal postpartum depression. Infant Behav Dev. 2019 Nov;57:101335. doi: 10.1016/j.infbeh.2019.101335. Epub 2019 Jun 27. PMID 31254811
• Feldman, R. (2007). Parent-Infant Synchrony: Biological Foundations and Developmental Outcomes. Current Directions in Psychological Science, 16(6), 340-345. doi: 10.1111/j.1467-8721.2007.00532
• Lee H, White-Traut R. Physiologic responses of preterm infants to the male and female voice in the NICU. J Pediatr Nurs. 2014 Jan-Feb;29(1):e3-5. doi: 10.1016/j.pedn.2013.04.007. Epub 2013 May 14. PMID 23685267
• Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10. PMID 29535067
• Saliba S, Gratier M, Filippa M, Devouche E, Esseily R (2020). Fathers' and Mothers' Infant Directed Speech Infuences Preterm Infant Behavioral State in the NICU. Journal of Nonverbal Behavior, 44:437-451. Doi: 10.1007/s10919-020-00335-1

Идентификаторы

NCT: NCT06462638 · CNR-IRIB-PRO-2024-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗