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Completed

NCT Number: NCT04689386

Effect of Chest Physiotherapy on the Development of Preterm Infants.

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.

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Key information

Conditions

Development, Infant Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome in Premature Infant Respiratory Tract Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Elche, Elche, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. Heart rate

    Time frame: From date of randomization until 1 month

    Heart rate will be measured with the pulse oximeter.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. Hospitalization time

    Time frame: At hospital discharge.

    The days of hospitalization will be collected from the clinical history.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Collaborators

  • Fundación para la Salud Infantil de la Comunidad Valenciana

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2020
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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