EEG and NIRS in Preterm Infants

August 15, 2025 updated by: Rocío Llamas-Ramos, University of Salamanca

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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • term and preterm babys
  • first month after birth

Exclusion Criteria:

  • intrumental delivery
  • pathology associated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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
Other: Massotherapy
Baby body massage with gliding
Placebo Comparator: Term group 1
To analize the brain activation and oxigenation using the Vojta Therapy
Other: 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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Actual)

October 2, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 28, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEGNIRS2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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