COntact RElationship in Neonatal Intensive Care Unit

Preterm Birth Clinical Trial

— CORE in NICU  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462638
• Other study ID #: CNR-IRIB-PRO-2024-007
• Status: Not yet recruiting
• Start date: November 1, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: June 2024
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Gennaro Tartarisco
• Phone: 3283377046
• Email: gennaro.tartarisco[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 31, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Postpartum Depression
• Premature Birth
• Preterm Birth

Intervention

Other:
• 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 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.
• 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).

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy	Messina

Sponsors (3)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo, UOC Neonatologia e UTIN, Presidio Ospedaliero G. F. Ingrassia di Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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

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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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