EEG and NIRS in Preterm Infants

NCT05410340 | Enrolling By Invitation

• 1 other identifier: EEGNIRS2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Preterm; Premature; Infant; Baby; Child

Outcome Measures

Primary Outcomes (2)

• EEG (Alpha, Beta, Theta)

  Brain activation

  Change from Baseline brain activation at 3 months

• NIRS

  Brain oxigenation

  Change from Baseline brain oxigenation at 3 months

Secondary Outcomes (1)

• Eye tracker

  Change from Baseline gaze fization at 6 months

Study Arms (4)

Preterm group 1

ACTIVE COMPARATOR

To analize the brain activation and oxigenation using the Vojta Therapy

Other: Vojta Therapy

Preterm Group 2

ACTIVE COMPARATOR

To analize the brain activation and oxigenation using massotherapy

Other: Massotherapy

Term group 1

PLACEBO COMPARATOR

To analize the brain activation and oxigenation using the Vojta Therapy

Other: Vojta Therapy

Term group 2

PLACEBO COMPARATOR

To analize the brain activation and oxigenation using massotherapy

Other: Massotherapy

Interventions

Vojta Therapy OTHER

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

Preterm group 1; Term group 1

Massotherapy OTHER

Baby body massage with gliding

Preterm Group 2; Term group 2

Eligibility Criteria

• Age: 7 Days - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• term and preterm babys
• first month after birth

You may not qualify if:

• intrumental delivery
• pathology associated

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Invesigator will not know which infants are premature or not
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 28, 2022
• First Posted: June 8, 2022
• Study Start: August 3, 2024
• Primary Completion: October 2, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

ES (1)