Effect of Chest Physiotherapy on the Development of Preterm Infants.

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome in Premature Infant; Development, Infant
• Interventions: Other: Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method; Other: Group II (GE-II) - expiratory flow increase technique

• Registration Number: NCT04689386
• Lead Sponsor: Universidad de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Study Start: 2021-02-26
• Primary Completion: 2024-02-06
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I Stimulation of "reflex rolling" from the Vojta method	Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method	-
Group II Expiratory flow increase technique	Group II (GE-II) - expiratory flow increase technique	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	Sat02 and will be measured with the pulse oximeter.
Measurements related to lung function (respiratory rate)	From date of randomization until 1 month	The values of respiratory rate will be those rebounded by mechanical ventilation or pulse oximeter.
Days of mechanical ventilation.	From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year	The days of mechanical ventilation will be collected from the clinical history.
Numbers of hospital admissions for respiratory infection up to 12 months of corrected age	Assessment of 12 months of corrected age.	The numbers of hospital admissions for respiratory infection up to 12 months of corrected age will be recorded through a questionnaire that will be delivered to the family.
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.	Alberta Infant Motor Scale consists of 58 items based on descriptions of postural control in supine decubitus (9 items), prone decubitus (21 items), sitting (12 items) and standing (16 items). It is designed for children from 0 to 18 months.
Measurements related to lung function (FiO2)	From date of randomization until 1 month	The values of FiO2 will be those rebounded by mechanical ventilation
Measurements related to lung function (PEEP and PIP)	From date of randomization until 1 month	The values of PEEP and PIP will be those rebounded by mechanical ventilation
Heart rate	From date of randomization until 1 month	Heart rate will be measured with the pulse oximeter.
Injury or respiratory failure	From date of randomization until 1 month	Injury or respiratory failure will be calculated using the following formula: PaO2 / FiO2
Hospitalization time	At hospital discharge.	The days of hospitalization will be collected from the clinical history.
Anthropometric measures	They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment after the intervention period, and at hospital discharge.	The weight measurement will be done through a scale or through the clinical history. Measurement of height and head circumference will be done with a tape measure or through the clinical history.
cephalic perimeter	They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.	Measurement cephalic perimeter will be done with a tape measure or through the clinical history.
Days of contribution of 02	From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year	The days of contribution of 02 greater than 21% will be collected from the clinical history.
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	The Premature Infant Pain Profile (PIPP) scale is based on mixed behavioral and physiological indicators. It has seven items and each item will be estimated from 0 to 3 to assess pain in premature infants.; The maximum score is 21, and in term newborns it is 18. According to the score obtained, it is concluded: * Minimal pain or no pain: 0 to 6 points; * Moderate pain: 7 to 12 points; * Intense or severe pain: if it is greater than 12 points
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	Pa02 and PaCO2 or PvO2 and PvO2 will be assessed with an arterial blood gas / arterialized blood / venous blood gas from the measurement carried out by the neonatal service. It will be recorded in the first evaluation, in the final evaluation (the day after finishing the intervention) and daily during the intervention.
Start time of autonomous feeding	At hospital discharge.	The age of the premature infant at the time of initiation of autonomous feeding will be collected from the clinical history.
Weight	They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.	The weight measurement will be done through a scale or through the clinical history.
Height	They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.	Measurement of height will be done with a tape measure or through the clinical history.
Family and personal history	First day of participation in the study	A semi-structured interview will record the history of the pregnancy (type of fertilization: natural or artificial; parity: single, twin, multiple; type of delivery: eutocic, dystocic, etc.) and family data (type of family, age of the mother / father, educational level, socioeconomic level, etc.).; Gestational age, gender, and APGAR score will be recorded from medical clinica.

Trial Locations

Locations (3)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital Universitario Torrecárdenas; 🇪🇸 Almería, Spain