Actively Recruiting

Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06462638

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

Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2025-05-01

80

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

I

Istituto per la Ricerca e l'Innovazione Biomedica

Lead Sponsor

S

Scienze Psicologiche,Pedagogiche,Università degli Studi di Palermo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring how contact, especially through voice and touch, between caregivers and moderately preterm infants in the Neonatal Intensive Care Unit (NICU) can support the infants' developmental and maturational processes. The study focuses on comparing the effects of the maternal voice, paternal voice, and a familiar non-parental voice, such as a NICU nurse's, on the infants' neurobehavioral states. It also considers the psychological condition of the parents, such as postpartum depression and anxiety, which may influence infant responses and parent-infant interactions. The study involves triads of mother, father, and moderately preterm infants born between 33 and 36 weeks gestation, who are medically stable and admitted to the NICU. Each infant will be assessed multiple times weekly over at least two weeks through audio/video recordings during interactions with each caregiver and the nurse. These interactions allow free use of voice and touch, while physiological parameters of both infants and adults are monitored with wearable devices. Additionally, maternal vocal pitch will be analyzed with artificial intelligence software to help detect postpartum depression alongside standard questionnaires. Participants will engage in assessments including the Neonatal Behavioural Assessment Scale (NBAS) and the Edinburgh Postnatal Depression Scale (EPDS). The study collects behavioral, neurophysiological, and psychological data to better understand early parent-infant communication and support. The involvement includes repeated observational sessions, questionnaire completion, and physiological monitoring. The research aims to improve support for parents and healthcare staff during the NICU hospitalization period, with the study planned through October 2026.

CONDITIONS

Brief Title

COntact RElationship in Neonatal Intensive Care Unit

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born between 33 and 36 weeks gestation with low birth weight around 2 kg and stable medical condition
  • Male and female parents aged 18 to 50 years
  • Life-threatening conditions for infants have been averted
Not Eligible

You will not qualify if you...

  • Infants with congenital anomalies, neurological disorders, genetic syndromes, or developmental atypicalities
  • Parents under 18 years old
  • Parents with diagnosed psychiatric disorders or sensory disabilities
  • Single parents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - At least 2 weeks

Participants are observed through repeated assessments of neurobehavioral states and physiological parameters during interactions with mother, father, and nurse. Audio and video recordings of cradle movements and vocalizations are collected during baseline, interaction, and post-interaction periods. Maternal vocal pitch is also evaluated to assess depressive or anxious states.

3 visits per week for at least 2 weeks

Trial Site Locations

Total: 1 location

1

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

Messina, Italy, 98164

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Research Team

G

Gennaro Tartarisco

M

Maria Valeria Maiorana

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Motor activity and spatial proximity: Relationships to infant emotions and maternal postpartum depression.

Ida Egmose, Mette Skovgaard Væver, Johanne Smith-Nielsen...

https://pubmed.ncbi.nlm.nih.gov/31254811

Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development.

Livio Provenzi, Sara Broso, Rosario Montirosso

https://pubmed.ncbi.nlm.nih.gov/29535067