EEG and NIRS in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vojta Therapy, Massotherapy.
- Who it may be relevant to
- Registry conditions: Premature Birth. Basic parameters: 7 Days — 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
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.
Interventions
- Other Vojta Therapy
Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level - Other Massotherapy
Baby body massage with gliding
Primary outcome measures
- EEG (Alpha, Beta, Theta) [Time frame: Change from Baseline brain activation at 3 months]
- NIRS [Time frame: Change from Baseline brain oxigenation at 3 months]
Secondary outcome measures (1)
- Eye tracker [Time frame: Change from Baseline gaze fization at 6 months]
Eligibility criteria
Inclusion criteria
- term and preterm babys
- first month after birth
Exclusion criteria
- intrumental delivery
- pathology associated
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Spain · 1 center
- University of Salamanca — Salamanca
Identifiers
NCT: NCT05410340 · EEGNIRS2022