EEG and NIRS in Preterm Infants

N/AEnrolling By InvitationNCT05410340

University of Salamanca80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Premature Birth

Interventions

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

MassotherapyOTHER

Baby body massage with gliding

Eligibility

Sex: ALLMin age: 7 DaysMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Salamanca

Salamanca, Salamanca, Spain

Outcomes

Primary Outcomes

EEG (Alpha, Beta, Theta)

Brain activation

Time frame: Change from Baseline brain activation at 3 months

NIRS

Brain oxigenation

Time frame: Change from Baseline brain oxigenation at 3 months

Secondary Outcomes

Eye tracker

Gaze fixation

Time frame: Change from Baseline gaze fization at 6 months

Data from ClinicalTrials.gov

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