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Trials / Completed

CompletedNCT04689386

Effect of Chest Physiotherapy on the Development of Preterm Infants.

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Universidad de Murcia · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGroup I (GE-I) - Stimulation of "reflex rolling" from the Vojta methodThis 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.
OTHERGroup II (GE-II) - expiratory flow increase techniqueThe 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.

Timeline

Start date
2021-02-26
Primary completion
2024-02-06
Completion
2024-12-31
First posted
2020-12-30
Last updated
2025-03-27

Locations

3 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04689386. Inclusion in this directory is not an endorsement.