EEG and NIRS in Preterm Infants

NCT ID: NCT05410340

Last Updated: 2025-08-22

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-03

Study Completion Date

2026-12-31

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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
Invesigator will not know which infants are premature or not

Study Groups

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Preterm group 1

To analize the brain activation and oxigenation using the Vojta Therapy

Group Type ACTIVE_COMPARATOR

Vojta Therapy

Intervention Type OTHER

Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level

Preterm Group 2

To analize the brain activation and oxigenation using massotherapy

Group Type ACTIVE_COMPARATOR

Massotherapy

Intervention Type OTHER

Baby body massage with gliding

Term group 1

To analize the brain activation and oxigenation using the Vojta Therapy

Group Type PLACEBO_COMPARATOR

Vojta Therapy

Intervention Type OTHER

Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level

Term group 2

To analize the brain activation and oxigenation using massotherapy

Group Type PLACEBO_COMPARATOR

Massotherapy

Intervention Type OTHER

Baby body massage with gliding

Interventions

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Vojta Therapy

Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level

Intervention Type OTHER

Massotherapy

Baby body massage with gliding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* term and preterm babys
* first month after birth

Exclusion Criteria

* intrumental delivery
* pathology associated
Minimum Eligible Age

7 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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RocĂ­o Llamas-Ramos

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Salamanca

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

Other Identifiers

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EEGNIRS2022

Identifier Type: -

Identifier Source: org_study_id

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