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EEG and NIRS in Preterm Infants

Primary Purpose

Premature Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vojta Therapy
Massotherapy
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Premature Birth focused on measuring Preterm, Premature, Infant, Baby, Child

Eligibility Criteria

7 Days - 1 Month (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • term and preterm babys
  • first month after birth

Exclusion Criteria:

  • intrumental delivery
  • pathology associated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Preterm group 1

    Preterm Group 2

    Term group 1

    Term group 2

    Arm Description

    To analize the brain activation and oxigenation using the Vojta Therapy

    To analize the brain activation and oxigenation using massotherapy

    To analize the brain activation and oxigenation using the Vojta Therapy

    To analize the brain activation and oxigenation using massotherapy

    Outcomes

    Primary Outcome Measures

    EEG (Alpha, Beta, Theta)
    Brain activation
    NIRS
    Brain oxigenation

    Secondary Outcome Measures

    Eye tracker
    Gaze fixation

    Full Information

    First Posted
    May 28, 2022
    Last Updated
    May 9, 2023
    Sponsor
    University of Salamanca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05410340
    Brief Title
    EEG and NIRS in Preterm Infants
    Official Title
    Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 3, 2023 (Anticipated)
    Primary Completion Date
    October 2, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Salamanca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants. Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups. Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Birth
    Keywords
    Preterm, Premature, Infant, Baby, Child

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    Invesigator will not know which infants are premature or not
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preterm group 1
    Arm Type
    Active Comparator
    Arm Description
    To analize the brain activation and oxigenation using the Vojta Therapy
    Arm Title
    Preterm Group 2
    Arm Type
    Active Comparator
    Arm Description
    To analize the brain activation and oxigenation using massotherapy
    Arm Title
    Term group 1
    Arm Type
    Placebo Comparator
    Arm Description
    To analize the brain activation and oxigenation using the Vojta Therapy
    Arm Title
    Term group 2
    Arm Type
    Placebo Comparator
    Arm Description
    To analize the brain activation and oxigenation using massotherapy
    Intervention Type
    Other
    Intervention Name(s)
    Vojta Therapy
    Intervention Description
    Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
    Intervention Type
    Other
    Intervention Name(s)
    Massotherapy
    Intervention Description
    Baby body massage with gliding
    Primary Outcome Measure Information:
    Title
    EEG (Alpha, Beta, Theta)
    Description
    Brain activation
    Time Frame
    Change from Baseline brain activation at 3 months
    Title
    NIRS
    Description
    Brain oxigenation
    Time Frame
    Change from Baseline brain oxigenation at 3 months
    Secondary Outcome Measure Information:
    Title
    Eye tracker
    Description
    Gaze fixation
    Time Frame
    Change from Baseline gaze fization at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    1 Month
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: term and preterm babys first month after birth Exclusion Criteria: intrumental delivery pathology associated
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inés Llamas-Ramos, PhD, PT
    Phone
    663005052
    Email
    inesllamas@usal.es

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    EEG and NIRS in Preterm Infants

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