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Search / Trial NCT06462638

COntact RElationship in Neonatal Intensive Care Unit

Launched by ISTITUTO PER LA RICERCA E L'INNOVAZIONE BIOMEDICA · Jun 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Preterm Birth Contact Relationship Postpartum Depression

ClinConnect Summary

The COntact RElationship in Neonatal Intensive Care Unit trial is studying how the voices of parents and caregivers affect the development of premature infants. Specifically, it looks at whether the sound of a mother's or father's voice helps these babies respond better and grow in a healthy way. The research also examines how the emotional well-being of parents, like postpartum depression or anxiety, might influence their baby's reactions. By understanding these relationships, the study hopes to improve support for both infants and their families during a challenging time.

To be eligible for this study, infants must be between 33 and 36 weeks old and weigh about 2 kg, while their parents should be adults aged 18 to 50. Participants can expect to engage in activities that include listening to their voices and possibly completing questionnaires about their emotional health. This research aims to enhance how parents interact with their babies in the NICU, potentially leading to earlier support for those experiencing emotional challenges after childbirth.

Gender

ALL

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.

About Istituto Per La Ricerca E L'innovazione Biomedica

Istituto per la Ricerca e l'Innovazione Biomedica (IRIB) is a leading clinical trial sponsor dedicated to advancing biomedical research and innovation. With a focus on enhancing patient outcomes through rigorous scientific investigation, IRIB collaborates with academic institutions, healthcare providers, and industry partners to conduct high-quality clinical trials. The institute is committed to fostering cutting-edge research that addresses unmet medical needs, ensuring compliance with ethical standards and regulatory requirements, and promoting the translation of research findings into clinical practice. Through its expertise and commitment to excellence, IRIB plays a pivotal role in shaping the future of healthcare.

Locations

Messina, , Italy

Patients applied

0 patients applied

Trial Officials

Gennaro Tartarisco

Principal Investigator

Istituto per la Ricerca e l'Innovazione Biomedica

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported