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

September 5, 2025 updated by: Hatice Adiguzel, PT, Sanko University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye), 46100
        • Kahramanmaras Sutcu Imam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 1/routin medical care and neonatal intensive care unit's daily care
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.
Experimental: 2/active chest physiotherapy in modified drainage positions
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.
Other: chest physiotherapy
diffferent chest physiotherapy methods
Experimental: 3/active chest physiotherapy in prone positions
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.
Other: chest physiotherapy
diffferent chest physiotherapy methods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: Before starting chest physiotherapy and up to15 minutes after ending therapy
heart rate of the preterm newborns
Before starting chest physiotherapy and up to15 minutes after ending therapy
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
on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
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
on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session
PaO₂
Time Frame: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
PaO₂ of the preterm newborns
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
blood pressure
Time Frame: on the time before starting chest physiotherapy and up to15 minutes after ending therapy
blood pressure of the preterm newborns
on the time before starting chest physiotherapy and up to15 minutes after ending therapy
respiratory rate
Time Frame: Before starting chest physiotherapy and up to15 minutes after ending therapy
respiratory rate of the preterm newborns
Before starting chest physiotherapy and up to15 minutes after ending therapy
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
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
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
on the time before starting chest physiotherapy and up to15 minutes after ending therapy
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
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
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
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
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).
before physiotherapy
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.
on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
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.
on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanko University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: hatice Adiguzel, PhD, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FTR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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