Clinical trial Recruiting at 1 site Observational Ages 18 to 50

Exploring caregiver-infant relationships in the 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)

Run by Istituto per la Ricerca e l'Innovazione Biomedica · NCT06462638 · Data updated 2026-11-12

This study looks at how the voices of parents and nurses affect the development of preterm infants in the NICU and how parents' mental health may play a role in this relationship.

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment80 (estimated)
SponsorIstituto per la Ricerca e l'Innovazione Biomedica
Academic / other
Locations1 site (Messina)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedApril 1, 2026
Study endsOctober 31, 2026
Registry record updatedMay 1, 2025
Trial IDNCT06462638 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include preterm infants aged 33 to 36 weeks and their parents aged 18 to 50 years.

Probably not a fit

Patients with congenital anomalies, neurological disorders, or parents with psychiatric disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the impact of caregiver contact relationships on the developmental processes of preterm infants. It focuses on how the neurobehavioral states of these infants respond to maternal and paternal voices compared to familiar non-parental voices, such as those of NICU nurses. Additionally, the study examines the psychological conditions of parents, particularly postpartum depression and anxiety, and how these factors may influence infant responses. The aim is to enhance understanding of the caregiver-infant dynamic in neonatal intensive care settings.

Why it matters

Potential benefit: If successful, this study could improve developmental outcomes for preterm infants by highlighting the importance of caregiver interactions.

How similar studies have gone: While the specific focus on paternal voice is less explored, similar studies have shown positive outcomes from caregiver interactions in neonatal settings.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.