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EEG and NIRS in Preterm Infants

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05410340
Enrollment
80
Registered
2022-06-08
Start date
2024-08-03
Completion date
2026-12-31
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Preterm, Premature, Infant, Baby, Child

Brief summary

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.

Interventions

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

Baby body massage with gliding

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)

Masking description

Invesigator will not know which infants are premature or not

Eligibility

Sex/Gender
ALL
Age
7 Days to 1 Months
Healthy volunteers
Yes

Inclusion criteria

* term and preterm babys * first month after birth

Exclusion criteria

* intrumental delivery * pathology associated

Design outcomes

Primary

MeasureTime frameDescription
EEG (Alpha, Beta, Theta)Change from Baseline brain activation at 3 monthsBrain activation
NIRSChange from Baseline brain oxigenation at 3 monthsBrain oxigenation

Secondary

MeasureTime frameDescription
Eye trackerChange from Baseline gaze fization at 6 monthsGaze fixation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026