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Completed

NCT Number: NCT05036603

Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns

Infants in the neonatal intensive care unit (NICU) may be lost due to risks such as being sensitive, frequent exposure to birth complications and being prone to infection. The most common causes of mortality in newborn babies in the world; Complications due to preterm delivery (28%), infections (26%) and perinatal asphyxia (23%) were reported. Respiratory problems are observed in 4-6% of newborns. These problems are also important causes of mortality in the neonatal period. Newborn infants are more likely to have respiratory distress due to difficulties in airway calibration, few collateral airways, flexible chest wall, poor airway stability, and low functional residual capacity.Invasive mechanical ventilation (IMV) is frequently used in the treatment of newborns with respiratory failure. Various ventilation modes and strategies are used to optimize mechanical ventilation and prevent ventilator-induced lung injury. Among the important issues to be considered in newborns connected to mechanical ventilator (MV); Choosing an appropriately sized endotracheal tube to reduce airway resistance and minimize respiratory workload, correct positioning, regular nursing care, chest physiotherapy, sedation-analgesia, and infection prevention are also included.

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Key information

About this study

Infants in the neonatal intensive care unit (NICU) may be lost due to risks such as being sensitive, frequent exposure to birth complications and being prone to infection. The most common causes of mortality in newborn babies in the world; Complications due to preterm delivery (28%), infections (26%) and perinatal asphyxia (23%) were reported. Respiratory problems are observed in 4-6% of newborns. These problems are also important causes of mortality in the neonatal period. Newborn infants are more likely to have respiratory distress due to difficulties in airway calibration, few collateral airways, flexible chest wall, poor airway stability, and low functional residual capacity.Invasive mechanical ventilation (IMV) is frequently used in the treatment of newborns with respiratory failure. Various ventilation modes and strategies are used to optimize mechanical ventilation and prevent ventilator-induced lung injury. Among the important issues to be considered in newborns connected to mechanical ventilator (MV); Choosing an appropriately sized endotracheal tube to reduce airway resistance and minimize respiratory workload, correct positioning, regular nursing care, chest physiotherapy, sedation-analgesia, and infection prevention are also included.The preference for using non-invasive mechanical ventilation (NIMV) modes in NICUs is also increasing. Despite this, the use of IMV is still often required in preterm infants in the need for respiratory support and in the treatment of respiratory failure. Today, extremely preterm infants are extubated quickly. Because prolonged IMV can be a very important risk factor in the development of Bronchopulmonary Dysplasia (BPD). The reason for this is the physiological characteristics of newborns such as airway maintenance and cleanliness, smaller airway calibration, reduction in collaterals, flexible chest wall, poor airway stability, and low functional residual capacity. A small amount of secretion in preterm infants can produce a large increase in airway resistance. This reduces airflow and without expiratory flow, secretions cannot be expelled. With chest physiotherapy (CP), adequate expiratory flow can be achieved without causing airway closure.Chest physiotherapy techniques (CP) create mechanical effects in the lung, increasing ventilation, facilitating the removal of secretions and preventing bronchial obstruction. This ensures correct protection of the airways and facilitates extubation. Prolonged intubation and increased length of stay in NICUs can also lead to complications such as atelectasis, respiratory infections and chronic lung disease. Decreased oxygenation and excessive accumulation of secretions cause widespread increase in airway resistance, leading to prolonged ventilation or oxygen support. Oxygen therapy is an integral part that is frequently used as respiratory support in NICUs. However, long-term oxygen therapy may cause excessive accumulation of bronchial secretions. This makes CP mandatory. Traditional CP has become an indispensable part of airway management in NICU settings to remove excess bronchial secretions and thereby increase oxygenation. There are many studies on CP in the literature.In some of these studies, it was found that it did not prevent atelectasis, that CP had no effect, or that CP accelerated weaning from MV. The role of CP in reducing respiratory morbidity in infants and neonates continues to be debated and more studies are needed. CP needs to be supported by well-controlled studies with large sample sizes, particularly regarding the techniques used and specific protocols. Therefore, in this study, it is aimed to compare the acute effects of CP methods applied in different positions in preterm newborns.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm newborns born <37 and >28 weeks due to MV or CPAP, hospitalized in the NICU and with a voluntary consent form from their families (with segmental lobar collapse as a result of Chest X-Ray, RDS/BPD/HMH/Atelectasis/Pneumonia/ Preterm newborns diagnosed with Chronic Pulmonary Disease or in stable condition with a thick and secretory focus on X-ray)
  • First-time infants who have not received any chest physiotherapy program

Exclusion criteria

  • Newborn infants who have been unstable in the last 2 days (SpO₂ <60 mmHg, heart rate, blood pressure, persistent apnea, excessive increases in respiratory rate, tachycardia, nasal wing breathing, cyanosis..etc)
  • Newborn infants with rib fracture, hemoptysis, diaphragmatic hernia, pulmonary hemorrhage, pneumothorax
  • Those diagnosed with any known heart disease or genetic disease
  • Those with osteopenia-osteoporosis or thrombocytopenia
  • Infants with any known neurological diagnosis (Abnormal MRI finding, Hydrocephalus, Chiari Malformation, Asphyxia, Periventricular Leukomolacia (PVL), Intraventricular Hemorrhage (IVH), Kernicterius, Hypoxic Ischemic Encephalopathy (HIE), Hydrocephalus)
  • Preterm infants weighing <1000 g
  • Infants born with congenital anomaly (Spina Bifida, Arthrogryposis Multiplex Congenita..etc)
  • Newborns undergoing any surgery

Treatment and study plan

chest physiotherapy

Other

diffferent chest physiotherapy methods

Primary outcomes

  1. heart rate

    Time frame: Before starting chest physiotherapy and up to15 minutes after ending therapy

    heart rate of the preterm newborns

  2. chest X-Ray

    Time frame: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session

    chest X-Ray of the preterm newborns

  3. arterial blood gases

    Time frame: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session

    arterial blood gases from the radial artery or from the umbilical catheter in infants with an umbilical catheter

  4. PaO₂

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    PaO₂ of the preterm newborns

  5. blood pressure

    Time frame: on the time before starting chest physiotherapy and up to15 minutes after ending therapy

    blood pressure of the preterm newborns

  6. respiratory rate

    Time frame: Before starting chest physiotherapy and up to15 minutes after ending therapy

    respiratory rate of the preterm newborns

  7. Peep (cm H₂O)

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    Peep (cm H₂O) of the preterm newborns

  8. Pip (cm H₂O)

    Time frame: on the time before starting chest physiotherapy and up to15 minutes after ending therapy

    Pip (cm H₂O) of the preterm newborns

  9. FİO₂ (%/mm Hg)

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    FİO₂ (%/mm Hg) of the preterm newborns

  10. O₂ Saturation (mmHg) (SpO₂)

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    O₂ Saturation (mmHg) (SpO₂) of the preterm newborns

Secondary outcomes

  1. Chest shape and type (barrel/pektusexcavatum..etc)

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    Chest shape and type (barrel/pektusexcavatum..etc) will be noted by inspection before and after chest physiotherapy.

  2. Respiratory stress

    Time frame: before physiotherapy

    The chest will be inspected before physiotherapy to note any signs of respiratory stress (chest retraction, expiratory sound, wheezing, etc.) and skin color (cyanosis/pink-bright-vivid/pale-white).

  3. the respiratory pattern

    Time frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

    Before and after chest physiotherapy, the physiotherapist will evaluate the respiratory pattern (tachypnea, periodic breathing, apnea, coughing, sneezing) by inspection.

  4. Daily nutrition type

    Time frame: on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy

    Daily nutrition type will be learned and respiratory problems encountered during feeding will be learned from the nurse/mother and noted.

Sponsors and collaborators

Lead sponsor

Sanko University

Other

Registry information

Acronym: therapy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2021
Registry last updated
Sep 12, 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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