EEG and NIRS in Preterm Infants

Not Applicable

Not yet recruiting

• Conditions: Premature Birth

• Registration Number: NCT05410340
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-28
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Study Start: 2024-08-03
• Primary Completion: 2024-10-02
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• term and preterm babys
• first month after birth

Exclusion Criteria

• intrumental delivery
• pathology associated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NIRS	Change from Baseline brain oxigenation at 3 months	Brain oxigenation
EEG (Alpha, Beta, Theta)	Change from Baseline brain activation at 3 months	Brain activation

Secondary Outcome Measures

Name	Time	Method
Eye tracker	Change from Baseline gaze fization at 6 months	Gaze fixation