Clinical trial NCT06462638: COntact RElationship in Neonatal Intensive Care Unit
Official title: Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Birth
Postpartum Depression
Keywords: preterm birth
contact relationship
postpartum depression
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo
name: UOC Neonatologia e UTIN, Presidio Ospedaliero G. F. Ingrassia di Palermo
First posted: 2024-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents and infants born moderately preterm admitted to the NICU experience an unique and complex condition. Babies born moderately preterm, often present challenges related to their not-yet-complete development. The may have organs not yet fully developed resulting in face respiratory and nutritional difficulties. They may have also problems maintaining a stable body temperature, requiring the use of incubators. The high risk of infection is due to their immature immune systems, requiring a sterile and controlled environment. For parents, the long course of intensive care is an extremely stressful and anxiety-provoking experience. Many parents feel overwhelmed by fear and anxiety, and sometimes feel a sense of guilt or responsibility.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal Behavioural Assessment Scale (NBAS)
timeFrame: It takes about 20-30 minutes to administer
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: The tool takes approximately 5 minutes to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Gennaro Tartarisco
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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