EEG and NIRS in Preterm Infants
Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Salamanca, Spain, 37007
- University of Salamanca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- term and preterm babys
- first month after birth
Exclusion Criteria:
- intrumental delivery
- pathology associated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Preterm group 1
To analize the brain activation and oxigenation using the Vojta Therapy
|
Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
|
|
Active Comparator: Preterm Group 2
To analize the brain activation and oxigenation using massotherapy
|
Baby body massage with gliding
|
|
Placebo Comparator: Term group 1
To analize the brain activation and oxigenation using the Vojta Therapy
|
Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
|
|
Placebo Comparator: Term group 2
To analize the brain activation and oxigenation using massotherapy
|
Baby body massage with gliding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG (Alpha, Beta, Theta)
Time Frame: Change from Baseline brain activation at 3 months
|
Brain activation
|
Change from Baseline brain activation at 3 months
|
|
NIRS
Time Frame: Change from Baseline brain oxigenation at 3 months
|
Brain oxigenation
|
Change from Baseline brain oxigenation at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye tracker
Time Frame: Change from Baseline gaze fization at 6 months
|
Gaze fixation
|
Change from Baseline gaze fization at 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEGNIRS2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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