Trials / Completed
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.