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COntact RElationship in Neonatal Intensive Care Unit

Recruitingn/aAges 18 Years - 50 YearsAllIstituto per la Ricerca e l'Innovazione Biomedica
NCT06462638 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 disorder

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📋 Eligibility rules (as published)
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.
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What it tests

  • Neurobehavioral states and physiological parameters evaluation
  • Maternal vocal pitch evaluation to assess depressive/anxious state
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Where

1 site
Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR), Messina 98164, Italy
Messina, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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