Exploring caregiver-infant relationships in the NICU
Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)
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 type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica Academic / other |
| Locations | 1 site (Messina) |
| Trial ID | NCT06462638 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include preterm infants aged 33 to 36 weeks and their parents aged 18 to 50 years.
Not a fit: Patients with congenital anomalies, neurological disorders, or parents with psychiatric disorders may not benefit from this study.
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 performed: While the specific focus on paternal voice is less explored, similar studies have shown positive outcomes from caregiver interactions in neonatal settings.
Eligibility criteria
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 this trial is running
Messina
- Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy — Messina, Italy (Recruiting)
Study contacts
- Principal investigator: Gennaro Tartarisco — Istituto per la Ricerca e l'Innovazione Biomedica
- Study coordinator: Gennaro Tartarisco
- Email: gennaro.tartarisco@irib.cnr.it
- Phone: 3283377046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.