Clinical trial NCT05036603: Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
Official title: Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Premature
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome
Mechanical Ventilation Complication
Mechanical Ventilation Pressure High
Oxygen Toxicity
Neonatal Respiratory Failure
Atelectasis Neonatal
Pneumonia Neonatal
Lobar Collapse
Chronic Liver Disease
Hyaline Membrane Disease
Keywords: Newborn
preterm
chest physiotherapy
neonatal intensive care unit
mechanical ventilation
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups; different chest physitherapy approach and 1 grup(control): routine medical care for newborns and neonatal intensive care unit's routin daily care
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: heart rate
timeFrame: Before starting chest physiotherapy and up to15 minutes after ending therapy
measure: chest X-Ray
timeFrame: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
measure: arterial blood gases
timeFrame: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
measure: PaO₂
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
measure: blood pressure
timeFrame: on the time before starting chest physiotherapy and up to15 minutes after ending therapy
measure: respiratory rate
timeFrame: Before starting chest physiotherapy and up to15 minutes after ending therapy
measure: Peep (cm H₂O)
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
measure: Pip (cm H₂O)
timeFrame: on the time before starting chest physiotherapy and up to15 minutes after ending therapy
measure: FİO₂ (%/mm Hg)
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
measure: O₂ Saturation (mmHg) (SpO₂)
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Secondary outcomes:
measure: Chest shape and type (barrel/pektusexcavatum..etc)
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
measure: Respiratory stress
timeFrame: before physiotherapy
measure: the respiratory pattern
timeFrame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
measure: Daily nutrition type
timeFrame: on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: hatice Adiguzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: