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Enrolling by Invitation

NCT Number: NCT05410340

EEG and NIRS 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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

7 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • term and preterm babys
  • first month after birth

Exclusion criteria

  • intrumental delivery
  • pathology associated

Treatment and study plan

Vojta Therapy

Other

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

Massotherapy

Other

Baby body massage with gliding

Primary outcomes

  1. EEG (Alpha, Beta, Theta)

    Time frame: Change from Baseline brain activation at 3 months

    Brain activation

  2. NIRS

    Time frame: Change from Baseline brain oxigenation at 3 months

    Brain oxigenation

Secondary outcomes

  1. Eye tracker

    Time frame: Change from Baseline gaze fization at 6 months

    Gaze fixation

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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