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

Preterm Birth Clinical Trial

— therapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036603
• Other study ID #: FTR
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Sanko University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 45 Days

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis Neonatal
• Bronchopulmonary Dysplasia
• Chronic Liver Disease
• Hyaline Membrane Disease
• Liver Diseases
• Mechanical Ventilation Complication
• Mechanical Ventilation Pressure High
• Neonatal Respiratory Failure
• Oxygen Toxicity
• Premature
• Premature Birth
• Preterm Birth
• Pulmonary Atelectasis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Other:
• chest physiotherapy
diffferent chest physiotherapy methods

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	heart rate of the preterm newborns	Before starting chest physiotherapy and up to15 minutes after ending therapy
Primary	chest X-Ray	chest X-Ray of the preterm newborns	on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
Primary	arterial blood gases	arterial blood gases from the radial artery or from the umbilical catheter in infants with an umbilical catheter	on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
Primary	PaO2	PaO2 of the preterm newborns	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Primary	blood pressure	blood pressure of the preterm newborns	on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Primary	respiratory rate	respiratory rate of the preterm newborns	Before starting chest physiotherapy and up to15 minutes after ending therapy
Primary	Peep (cm H2O)	Peep (cm H2O) of the preterm newborns	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Primary	Pip (cm H2O)	Pip (cm H2O) of the preterm newborns	on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Primary	FIO2 (%/mm Hg)	FIO2 (%/mm Hg) of the preterm newborns	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Primary	O2 Saturation (mmHg) (SpO2)	O2 Saturation (mmHg) (SpO2) of the preterm newborns	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Secondary	Chest shape and type (barrel/pektusexcavatum..etc)	Chest shape and type (barrel/pektusexcavatum..etc) will be noted by inspection before and after chest physiotherapy.	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Secondary	Respiratory stress	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).	before physiotherapy
Secondary	the respiratory pattern	Before and after chest physiotherapy, the physiotherapist will evaluate the respiratory pattern (tachypnea, periodic breathing, apnea, coughing, sneezing) by inspection.	on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Secondary	Daily nutrition type	Daily nutrition type will be learned and respiratory problems encountered during feeding will be learned from the nurse/mother and noted.	on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy