EEG and NIRS in Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants

Conditions
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Premature Birth

Intervention / Treatment
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* Other: Vojta Therapy
* Other: Massotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: term and preterm babys first month after birth Exclusion Criteria: intrumental delivery pathology associated

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preterm group 1<br>To analize the brain activation and oxigenation using the Vojta Therapy | Other: Vojta Therapy<br>* Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level<br>|
| Active Comparator: Preterm Group 2<br>To analize the brain activation and oxigenation using massotherapy | Other: Massotherapy<br>* Baby body massage with gliding<br>|
| Placebo Comparator: Term group 1<br>To analize the brain activation and oxigenation using the Vojta Therapy | Other: Vojta Therapy<br>* Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level<br>|
| Placebo Comparator: Term group 2<br>To analize the brain activation and oxigenation using massotherapy | Other: Massotherapy<br>* Baby body massage with gliding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG (Alpha, Beta, Theta) | Brain activation | Change from Baseline brain activation at 3 months | 
| NIRS | Brain oxigenation | Change from Baseline brain oxigenation at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye tracker | Gaze fixation | Change from Baseline gaze fization at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, Premature, Infant, Baby, Child