Premature BirthNCT05410340
EEG and NIRS in Preterm Infants
A study testing Vojta Therapy and Massotherapy in people with Premature Birth, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Vojta Therapy and Massotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 3 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- term and preterm babys
- first month after birth
Who cannot join
- intrumental delivery
- pathology associated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
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
- Being tested
- Vojta Therapy, Massotherapy
- Keywords
- Preterm, Premature, Infant, Baby, Child
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
MassotherapyOther
Baby body massage with gliding
| Study group | Role | What they receive |
|---|---|---|
| Preterm group 1 | Active comparator | To analize the brain activation and oxigenation using the Vojta Therapy Receives: Other: Vojta Therapy |
| Preterm Group 2 | Active comparator | To analize the brain activation and oxigenation using massotherapy Receives: Other: Massotherapy |
| Term group 1 | Placebo comparator | To analize the brain activation and oxigenation using the Vojta Therapy Receives: Other: Vojta Therapy |
| Term group 2 | Placebo comparator | To analize the brain activation and oxigenation using massotherapy Receives: Other: Massotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG (Alpha, Beta, Theta)
Brain activation
Measured: Change from Baseline brain activation at 3 months
NIRS
Brain oxigenation
Measured: Change from Baseline brain oxigenation at 3 months
Secondary outcomes (1)
Eye tracker
Gaze fixation
Measured: Change from Baseline gaze fization at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start3 Aug 2024
- Primary completion2 Oct 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410340
- Sponsor's protocol ID
- EEGNIRS2022
- Status last verified
- Aug 2025
- First submitted
- 28 May 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
- ClinicalTrials.gov ID
- NCT05410340
- Acronym / sponsor ID
- EEGNIRS2022
- Conditions
- Premature Birth
- Keywords
- Preterm, Premature, Infant, Baby, Child
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm group 1 | Active comparator | Other: Vojta TherapyTo analize the brain activation and oxigenation using the Vojta Therapy |
| Preterm Group 2 | Active comparator | Other: MassotherapyTo analize the brain activation and oxigenation using massotherapy |
| Term group 1 | Placebo comparator | Other: Vojta TherapyTo analize the brain activation and oxigenation using the Vojta Therapy |
| Term group 2 | Placebo comparator | Other: MassotherapyTo analize the brain activation and oxigenation using massotherapy |
Who may qualify
- Ages
- 7 days to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- term and preterm babys
- first month after birth
Key exclusion criteria (2 listed)
- intrumental delivery
- pathology associated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta TherapyMinimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level | Other | Preterm group 1, Term group 1 |
| MassotherapyBaby body massage with gliding | Other | Preterm Group 2, Term group 2 |
Primary outcome
EEG (Alpha, Beta, Theta)
Time frame: Change from Baseline brain activation at 3 months
Brain activation
NIRS
Time frame: Change from Baseline brain oxigenation at 3 months
Brain oxigenation
1 secondary outcome
Eye tracker
Time frame: Change from Baseline gaze fization at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Birth
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy and Massotherapy in people with Premature Birth, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (Alpha, Beta, Theta) (time frame: Change from Baseline brain activation at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.