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

Primary Purpose

Preterm Birth, Premature, Bronchopulmonary Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
chest physiotherapy
Sponsored by
Sanko University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring Newborn, preterm, chest physiotherapy, neonatal intensive care unit, mechanical ventilation

Eligibility Criteria

1 Day - 45 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kahramanmaras Sutcu Imam University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1/routin medical care and neonatal intensive care unit's daily care

2/active chest physiotherapy in modified drainage positions

3/active chest physiotherapy in prone positions

Arm Description

Group 1 (n=20) routine medical treatment for newborns on mechanical ventilator respiratory support and CPAP; Appropriate antibiotics given according to the needs of the baby, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care will be provided.

Group 2 (n=20) newborns on mechanical ventilator respiratory support and CPAP; A single session of active chest physiotherapy (CP) will be applied using modified drainage positions (avoiding the trendelenburg position, excessive position change and avoiding hand contact in babies younger than 30 weeks or who are sensitive to position change). Active CP in various modified drainage positions; It will consist of percussion and vibration methods with proprioceptive replacement stimulations. After these methods, aspiration will be performed and a suitable position will be given to the lobe that is desired to be ventilated. In addition, these patients will be given routine medical treatment consisting of appropriate antibiotics, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care.

Group 3 (n=20) newborns on mechanical ventilator respiratory support and CPAP; a single session of active chest physiotherapy treatment to be applied only in the prone position; Starting with proprioceptive stimulation, percussion and vibration methods will be applied. After these methods, aspiration will be performed and a suitable position will be given to the lobe that is desired to be ventilated. In addition, these patients will be given routine medical treatment consisting of appropriate antibiotics, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care.

Outcomes

Primary Outcome Measures

heart rate
heart rate of the preterm newborns
chest X-Ray
chest X-Ray of the preterm newborns
arterial blood gases
arterial blood gases from the radial artery or from the umbilical catheter in infants with an umbilical catheter
PaO₂
PaO₂ of the preterm newborns
blood pressure
blood pressure of the preterm newborns
respiratory rate
respiratory rate of the preterm newborns
Peep (cm H₂O)
Peep (cm H₂O) of the preterm newborns
Pip (cm H₂O)
Pip (cm H₂O) of the preterm newborns
FİO₂ (%/mm Hg)
FİO₂ (%/mm Hg) of the preterm newborns
O₂ Saturation (mmHg) (SpO₂)
O₂ Saturation (mmHg) (SpO₂) of the preterm newborns

Secondary Outcome Measures

Chest shape and type (barrel/pektusexcavatum..etc)
Chest shape and type (barrel/pektusexcavatum..etc) will be noted by inspection before and after chest physiotherapy.
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).
the respiratory pattern
Before and after chest physiotherapy, the physiotherapist will evaluate the respiratory pattern (tachypnea, periodic breathing, apnea, coughing, sneezing) by inspection.
Daily nutrition type
Daily nutrition type will be learned and respiratory problems encountered during feeding will be learned from the nurse/mother and noted.

Full Information

First Posted
August 18, 2021
Last Updated
August 19, 2022
Sponsor
Sanko University
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1. Study Identification

Unique Protocol Identification Number
NCT05036603
Brief Title
Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
Acronym
therapy
Official Title
Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanko University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1/routin medical care and neonatal intensive care unit's daily care
Arm Type
No Intervention
Arm Description
Group 1 (n=20) routine medical treatment for newborns on mechanical ventilator respiratory support and CPAP; Appropriate antibiotics given according to the needs of the baby, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care will be provided.
Arm Title
2/active chest physiotherapy in modified drainage positions
Arm Type
Experimental
Arm Description
Group 2 (n=20) newborns on mechanical ventilator respiratory support and CPAP; A single session of active chest physiotherapy (CP) will be applied using modified drainage positions (avoiding the trendelenburg position, excessive position change and avoiding hand contact in babies younger than 30 weeks or who are sensitive to position change). Active CP in various modified drainage positions; It will consist of percussion and vibration methods with proprioceptive replacement stimulations. After these methods, aspiration will be performed and a suitable position will be given to the lobe that is desired to be ventilated. In addition, these patients will be given routine medical treatment consisting of appropriate antibiotics, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care.
Arm Title
3/active chest physiotherapy in prone positions
Arm Type
Experimental
Arm Description
Group 3 (n=20) newborns on mechanical ventilator respiratory support and CPAP; a single session of active chest physiotherapy treatment to be applied only in the prone position; Starting with proprioceptive stimulation, percussion and vibration methods will be applied. After these methods, aspiration will be performed and a suitable position will be given to the lobe that is desired to be ventilated. In addition, these patients will be given routine medical treatment consisting of appropriate antibiotics, enteral-parenteral nutrition, oral or nebulizer drugs for softening the secretion, vitamin supplements and routine nursing care.
Intervention Type
Other
Intervention Name(s)
chest physiotherapy
Intervention Description
diffferent chest physiotherapy methods
Primary Outcome Measure Information:
Title
heart rate
Description
heart rate of the preterm newborns
Time Frame
Before starting chest physiotherapy and up to15 minutes after ending therapy
Title
chest X-Ray
Description
chest X-Ray of the preterm newborns
Time Frame
on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
Title
arterial blood gases
Description
arterial blood gases from the radial artery or from the umbilical catheter in infants with an umbilical catheter
Time Frame
on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
Title
PaO₂
Description
PaO₂ of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Title
blood pressure
Description
blood pressure of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Title
respiratory rate
Description
respiratory rate of the preterm newborns
Time Frame
Before starting chest physiotherapy and up to15 minutes after ending therapy
Title
Peep (cm H₂O)
Description
Peep (cm H₂O) of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Title
Pip (cm H₂O)
Description
Pip (cm H₂O) of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Title
FİO₂ (%/mm Hg)
Description
FİO₂ (%/mm Hg) of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Title
O₂ Saturation (mmHg) (SpO₂)
Description
O₂ Saturation (mmHg) (SpO₂) of the preterm newborns
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Secondary Outcome Measure Information:
Title
Chest shape and type (barrel/pektusexcavatum..etc)
Description
Chest shape and type (barrel/pektusexcavatum..etc) will be noted by inspection before and after chest physiotherapy.
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Title
Respiratory stress
Description
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).
Time Frame
before physiotherapy
Title
the respiratory pattern
Description
Before and after chest physiotherapy, the physiotherapist will evaluate the respiratory pattern (tachypnea, periodic breathing, apnea, coughing, sneezing) by inspection.
Time Frame
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Title
Daily nutrition type
Description
Daily nutrition type will be learned and respiratory problems encountered during feeding will be learned from the nurse/mother and noted.
Time Frame
on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
45 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hatice Adiguzel, PhD
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaraş
ZIP/Postal Code
46100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

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

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