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CompletedNCT05805254

Neurofunctional Study of Preterm Infants' Brain Activity

Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
IRCCS Burlo Garofolo · Academic / Other
Sex
All
Age
28 Days
Healthy volunteers
Not accepted

Summary

During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. In preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (KMC), are actively promoted. Studies carried out with electroencephalography showed that preterm infants who participated in KMC interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. It has also been observed that KMC carried out in preterm infant with gestational age \<33 weeks promotes adequate development of the primary motor cortex during adolescence. Recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. After few days of life, the infant's brain picks up messages from the human context and interacts with them. For example, a study using near-infrared spectroscopy (NIRS) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. Similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. The aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) KMC and 2) listening to their mother's voice, using optical topography, a multichannel NIRS system.

Conditions

Timeline

Start date
2018-03-25
Primary completion
2022-08-08
Completion
2022-08-08
First posted
2023-04-07
Last updated
2023-04-12

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05805254. Inclusion in this directory is not an endorsement.