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Neurofunctional Study of Preterm Infants' Brain Activity

Sponsor
IRCCS Burlo Garofolo (Other)
Overall Status
Completed
CT.gov ID
NCT05805254
Collaborator
(none)
30
Enrollment
1
Location
52.5
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions
    Actual Study Start Date :
    Mar 25, 2018
    Actual Primary Completion Date :
    Aug 8, 2022
    Actual Study Completion Date :
    Aug 8, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants [During hospital stay, between 30 to 36 weeks of postmenstrual age]

      Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values

    Secondary Outcome Measures

    1. Values of cortical oxy-haemoglobin (HbO2) during the experience of listening the mother's voice and the voice of an unknown woman in preterm infants [During hospital stay, between 30 to 36 weeks of postmenstrual age]

      Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Burlo Garofolo Trieste Italy 34137

    Sponsors and Collaborators

    • IRCCS Burlo Garofolo

    Investigators

    • Study Director: Stefano Bembich, MSC, IRCCS materno infantile Burlo Garofolo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IRCCS Burlo Garofolo
    ClinicalTrials.gov Identifier:
    NCT05805254
    Other Study ID Numbers:
    • RC 02/17
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IRCCS Burlo Garofolo
    Preterm infant
    Kangaroo Mother care
    family-centered interventions
    near-infrared spectroscopy
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Apr 12, 2023