Effect of Chest Physiotherapy on the Development of Preterm Infants.

NCT04689386 | Completed

• 1 other identifier: 74244433
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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

Development, Infant; Respiratory Distress Syndrome in Premature Infant

Keywords

Premature Infant; Respiratory Distress Syndrome; Chest Physiotherapy; Development

Outcome Measures

Primary Outcomes (1)

• Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age

  The motor area of the Bayley III scale will be measured at 3, 6, 9 and 12 months of corrected age. The motor scale has two subscales, the gross motor scale and the fine motor scale. This motor scale is made up of 138 items (the gross motor scale is made up of 72 items and the fine motor scale of 66 items) through which it evaluates the degree of body control, coordination of large muscle masses and skill manipulative of hands and fingers.

  at 3, 6, 9 and 12 months of corrected age.

Secondary Outcomes (19)

• Motor activity of the premature infant measured through the Alberta Infant Motor Scale (AIMS) at term age, at 3, 6, 9 and 12 months of corrected age

  at term age, at 3, 6, 9 and 12 months of corrected age.

• Pain during the intervention measured through the PIPP scale

  Daily in all interventions, that is, every day that the intervention is applied during the month of the intervention period

• Measurements related to lung function (PaO2 and PaCO2 or PvO2 and PvO2)

  The measurement performed by the neonatal service will be recorded. It will be recorded in the first assessment, in the final assessment (the day after finishing the intervention) and daily during the month of the intervention period

• Measurements related to lung function (SatO2)

  The day of the initial and final evaluation (the day after finishing the intervention) in the three groups. In addition, they will be measured before and after each intervention in GE-I and GE-II during the month that the intervention lasts.

• Measurements related to lung function (respiratory rate)

  From date of randomization until 1 month

Study Arms (3)

Group I Stimulation of "reflex rolling" from the Vojta method

EXPERIMENTAL

Other: Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method

Group II Expiratory flow increase technique

EXPERIMENTAL

Other: Group II (GE-II) - expiratory flow increase technique

Control Group

NO INTERVENTION

Routine intervention in the NICU with mechanical ventilation.

Interventions

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

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 I Stimulation of "reflex rolling" from the Vojta method

Group II (GE-II) - expiratory flow increase technique OTHER

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.

Group II Expiratory flow increase technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm Infants \<32 gestational age
• Admitted to the NICU
• With SDR
• Hemodynamically stable
• Stable convulsive pictures
• Controlled thermoregulation
• Mechanical ventilation (invasive or non-invasive)
• Parents / guardians of legal age, with sufficient cognitive ability to understand consent
• Signature of consent

You may not qualify if:

• Periventricular leukomalacia
• Grade III and IV intraventricular hemorrhage
• Rib fracture
• Asphyxia at birth
• Necrotizing enterocolitis \> or = II B
• Abandoned Criteria:
• Appearance of any of the complications mentioned above
• Hospital transfer
• Hospital discharge (if the intervention at home cannot be followed)
• Voluntary decision of parents / guardians to abandon the study
• Medical decision

Sponsors & Collaborators

• Universidad de Murcia: lead
• Fundación para la Salud Infantil de la Comunidad Valenciana: collaborator

Study Sites (3)

Hospital General Universitario de Elche

Elche, Alicante, 03292, Spain

Location

Hospital Universitario Torrecárdenas

Almería, Almería, 04009, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

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MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Degree in Physiotherapy

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: December 30, 2020
• Study Start: February 26, 2021
• Primary Completion: February 6, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)