EEG and NIRS in Preterm Infants

Sponsor

University of Salamanca (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05410340

Collaborator

(none)

Enrollment

Arms

14.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Other: Vojta Therapy Other: Massotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

Invesigator will not know which infants are premature or not

Primary Purpose:

Screening

Official Title:

Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants

Anticipated Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

Oct 2, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Preterm group 1 To analize the brain activation and oxigenation using the Vojta Therapy	Other: Vojta Therapy Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
Active Comparator: Preterm Group 2 To analize the brain activation and oxigenation using massotherapy	Other: Massotherapy Baby body massage with gliding
Placebo Comparator: Term group 1 To analize the brain activation and oxigenation using the Vojta Therapy	Other: Vojta Therapy Minimal digital pressure at costal level to assess the activation and oxygenation occurring at the cerebral level
Placebo Comparator: Term group 2 To analize the brain activation and oxigenation using massotherapy	Other: Massotherapy Baby body massage with gliding

Outcome Measures

Primary Outcome Measures

EEG (Alpha, Beta, Theta) [Change from Baseline brain activation at 3 months]
Brain activation
NIRS [Change from Baseline brain oxigenation at 3 months]
Brain oxigenation

Secondary Outcome Measures

Eye tracker [Change from Baseline gaze fization at 6 months]
Gaze fixation

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Days to 1 Month

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

term and preterm babys
first month after birth

Exclusion Criteria:

intrumental delivery
pathology associated

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rocío Llamas-Ramos, Associate Professor, University of Salamanca

ClinicalTrials.gov Identifier:

NCT05410340

Other Study ID Numbers:

EEGNIRS2022

First Posted:

Jun 8, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rocío Llamas-Ramos, Associate Professor, University of Salamanca

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jun 8, 2022