Neurofunctional Study of Preterm Infants' Brain Activity

NCT ID: NCT05805254

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-25

Study Completion Date

2022-08-08

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Activity Preterm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* gestational age at birth ≤32 weeks
* absence of brain injury and neurological problems
* newborn-mother pairs in KMC
* adherence to research by parents.

Exclusion Criteria

* contraindications to KMC and NIRS, according to internal protocol
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Bembich, MSC

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

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IRCCS Burlo Garofolo

Trieste, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RC 02/17

Identifier Type: -

Identifier Source: org_study_id

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