Effect of Chest Physiotherapy on the Development of Preterm Infants.

Respiratory Distress Syndrome in Premature Infant Clinical Trial

Official title:

Efecto de la Fisioterapia Respiratoria Sobre el Desarrollo de Niños/as Prematuros. Estudio Longitudinal.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689386
• Other study ID #: 74244433
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Universidad de Murcia
• Contact: Ana Igual Blasco, Physiotherapist
• Phone: 600316233
• Email: a.igualb[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Development, Infant
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Torrecárdenas	Almería
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital General Universitario de Elche	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Murcia	Fundación para la Salud Infantil de la Comunidad Valenciana

Country where clinical trial is conducted

Spain, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	at term age, at 3, 6, 9 and 12 months of corrected age.
Secondary	Pain during the intervention measured through the PIPP scale	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	Daily in all interventions, that is, every day that the intervention is applied during the month of the intervention period
Secondary	Measurements related to lung function (PaO2 and PaCO2 or PvO2 and PvO2)	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.	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
Secondary	Measurements related to lung function (SatO2)	Sat02 and will be measured with the pulse oximeter.	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.
Secondary	Measurements related to lung function (respiratory rate)	The values of respiratory rate will be those rebounded by mechanical ventilation or pulse oximeter.	From date of randomization until 1 month
Secondary	Measurements related to lung function (FiO2)	The values of FiO2 will be those rebounded by mechanical ventilation	From date of randomization until 1 month
Secondary	Measurements related to lung function (PEEP and PIP)	The values of PEEP and PIP will be those rebounded by mechanical ventilation	From date of randomization until 1 month
Secondary	Heart rate	Heart rate will be measured with the pulse oximeter.	From date of randomization until 1 month
Secondary	Injury or respiratory failure	Injury or respiratory failure will be calculated using the following formula: PaO2 / FiO2	From date of randomization until 1 month
Secondary	Days of contribution of 02	The days of contribution of 02 greater than 21% will be collected from the clinical history.	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
Secondary	Days of mechanical ventilation.	The days of mechanical ventilation will be collected from the clinical history.	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
Secondary	Start time of autonomous feeding	The age of the premature infant at the time of initiation of autonomous feeding will be collected from the clinical history.	At hospital discharge.
Secondary	Hospitalization time	The days of hospitalization will be collected from the clinical history.	At hospital discharge.
Secondary	Anthropometric measures	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.	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.
Secondary	Weight	The weight measurement will be done through a scale or through the clinical history.	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.
Secondary	Height	Measurement of height will be done with a tape measure or through the clinical history.	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.
Secondary	cephalic perimeter	Measurement cephalic perimeter will be done with a tape measure or through the clinical history.	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.
Secondary	Family and personal history	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.	First day of participation in the study
Secondary	Numbers of hospital admissions for respiratory infection up to 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.	Assessment of 12 months of corrected age.