Effect of Chest Physiotherapy on the Development of Preterm Infants.

January 6, 2024 updated by: Ana Igual Blasco, Universidad de Murcia

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ana Igual Blasco, Physiotherapist
  • Phone Number: 600316233
  • Email: a.igualb@um.es

Study Locations

  • Spain
      • Almería, Spain, 04009
        • Recruiting
        • Hospital Universitario Torrecárdenas
        • Contact:
    • Alicante
      • Elche, Alicante, Spain, 03292
        • Recruiting
        • Hospital General Universitario de Elche
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I Stimulation of "reflex rolling" from the Vojta method
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.
Experimental: Group II Expiratory flow increase technique
Other: 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.
No Intervention: Control Group
Routine intervention in the NICU with mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Pain during the intervention measured through the PIPP scale
Time Frame: 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
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: From date of randomization until 1 month
The values of respiratory rate will be those rebounded by mechanical ventilation or pulse oximeter.
From date of randomization until 1 month
Measurements related to lung function (FiO2)
Time Frame: From date of randomization until 1 month
The values of FiO2 will be those rebounded by mechanical ventilation
From date of randomization until 1 month
Measurements related to lung function (PEEP and PIP)
Time Frame: From date of randomization until 1 month
The values of PEEP and PIP will be those rebounded by mechanical ventilation
From date of randomization until 1 month
Heart rate
Time Frame: From date of randomization until 1 month
Heart rate will be measured with the pulse oximeter.
From date of randomization until 1 month
Injury or respiratory failure
Time Frame: From date of randomization until 1 month
Injury or respiratory failure will be calculated using the following formula: PaO2 / FiO2
From date of randomization until 1 month
Days of contribution of 02
Time Frame: 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.
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
Days of mechanical ventilation.
Time Frame: 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.
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
Start time of autonomous feeding
Time Frame: At hospital discharge.
The age of the premature infant at the time of initiation of autonomous feeding will be collected from the clinical history.
At hospital discharge.
Hospitalization time
Time Frame: At hospital discharge.
The days of hospitalization will be collected from the clinical history.
At hospital discharge.
Anthropometric measures
Time Frame: 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.
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.
Weight
Time Frame: 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.
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.
Height
Time Frame: 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.
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.
cephalic perimeter
Time Frame: 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.
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.
Family and personal history
Time Frame: 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.
First day of participation in the study
Numbers of hospital admissions for respiratory infection up to 12 months of corrected age
Time Frame: 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.
Assessment of 12 months of corrected age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Collaborators

Fundación para la Salud Infantil de la Comunidad Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74244433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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