EEG and NIRS in Preterm Infants

University of Salamanca

Status: Invitation-only

Conditions: Premature Birth

Treatments: Other: Vojta Therapy; Other: Massotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05410340

EEGNIRS2022

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 days to 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• term and preterm babys
• first month after birth

Exclusion criteria

• intrumental delivery
• pathology associated

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 4 patient groups, including a placebo group

Preterm group 1

Active Comparator group

Description:

To analize the brain activation and oxigenation using the Vojta Therapy

Treatment:

Other: Vojta Therapy

Preterm Group 2

Active Comparator group

Description:

To analize the brain activation and oxigenation using massotherapy

Treatment:

Other: Massotherapy

Term group 1

Placebo Comparator group

Description:

To analize the brain activation and oxigenation using the Vojta Therapy

Treatment:

Other: Vojta Therapy

Term group 2

Placebo Comparator group

Description:

To analize the brain activation and oxigenation using massotherapy

Treatment:

Other: Massotherapy