CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method +1 moreother
Likely dose
Not stated in record
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Search/NCT04689386
NCT04689386N/ACompleted

Efecto De La Fisioterapia Respiratoria Sobre El Desarrollo De Niños/as Prematuros. Estudio Longitudinal.

Universidad de Murcia·interventional·Posted Dec 30, 2020·Updated Mar 27, 2025

In Brief

A clinical study evaluating Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method and Group II (GE-II) - expiratory flow increase technique for Development, Infant and Respiratory Distress Syndrome in Premature Infant. Completed, enrolled 51 participants across 3 sites.

Detailed Summary

The aim of this study is to investigate the effect of the stimulation of "reflex rolling" from the Vojta method and the effect of the expiratory flow increase technique on the development of the preterm infants. In the same way, it will be assessed whether the application of these techniques produce pain. This application will be carried out in preterm infants of less than 32 weeks of gestation with neonatal respiratory distress syndrome (SDR) and carriers of mechanical ventilation. The intervention will take place in the neonatal intensive care unit (NICU) The intervention period is one month (4 weeks) and different follow-ups will be carried out at term age, at 3, 6, 9 and 12 months of corrected age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 30, 2020
Enrollment StartFeb 26, 2021
Primary CompletionFeb 6, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.5 years ago

Interventions

Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta methodother

This manoeuvre does not require the newborn to be moved, but only a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface. A digital pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. A one minute stimulus will be performed on each side. The intervention will be repeated twice a day, ensuring that the period between one intervention and another is at least two hours.

Group II (GE-II) - expiratory flow increase techniqueother

The technique adapted to the premature infant will be performed. This maneuver consists of slowly applying light pressure to the infant's chest with one hand, obliquely, starting from the end of the inspiratory plateau until the end of expiration, which is prolonged. The hand should be placed between the sternal notch and the xiphoid process of the newborn's sternum. The therapist's other hand is placed on the last ribs (without applying pressure) as a bridge, of which the columns are the thumb and forefinger (or middle finger). Therefore, contact with the infant's abdomen is avoided and the expansion of the lower rib is limited, allowing a better displacement of the diaphragm and avoiding an increase in intra-abdominal pressure. The maneuver will be repeated three times, respecting the infant's responses and their physiological constants. The intervention will be repeated twice a day, trying to ensure that the period between one intervention and another is at least 2 hours.