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Preterm BirththerapyNCT05036603

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

A study testing chest physiotherapy in people with Preterm Birth and Premature, run by Sanko University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 1 day to 45 days
What is being tested?
chest physiotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2022to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 45 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kahramanmaras Sutcu Imam University

    Kahramanmaraş, 46100

Other trials in Turkey (Türkiye)

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.

Read the 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.

Being tested
chest physiotherapy
Keywords
Newborn, preterm, chest physiotherapy, neonatal intensive care unit, mechanical ventilation
Medical subject headings
Premature Birth, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Pulmonary Atelectasis, Hyaline Membrane Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chest physiotherapyOther

    diffferent chest physiotherapy methods

Study groups in NCT05036603
Study groupRoleWhat they receive
1/routin medical care and neonatal intensive care unit's daily careNo interventionGroup 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.
2/active chest physiotherapy in modified drainage positionsExperimentalGroup 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.
Receives: Other: chest physiotherapy
3/active chest physiotherapy in prone positionsExperimentalGroup 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.
Receives: Other: chest physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. heart rate

    heart rate of the preterm newborns

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

  2. chest X-Ray

    chest X-Ray of the preterm newborns

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

  3. arterial blood gases

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

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

  4. PaO₂

    PaO₂ of the preterm newborns

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

  5. blood pressure

    blood pressure of the preterm newborns

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

  6. respiratory rate

    respiratory rate of the preterm newborns

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

  7. Peep (cm H₂O)

    Peep (cm H₂O) of the preterm newborns

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

  8. Pip (cm H₂O)

    Pip (cm H₂O) of the preterm newborns

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

  9. FİO₂ (%/mm Hg)

    FİO₂ (%/mm Hg) of the preterm newborns

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

  10. O₂ Saturation (mmHg) (SpO₂)

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

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

Secondary outcomes (4)
  1. Chest shape and type (barrel/pektusexcavatum..etc)

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

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

  2. 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).

    Measured: before physiotherapy

  3. the respiratory pattern

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

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

  4. Daily nutrition type

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start1 Apr 2022
  3. Primary completion30 Jul 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05036603
Sponsor's protocol ID
FTR
Acronym
therapy
Status last verified
Aug 2022
First submitted
18 Aug 2021
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no plan to make individual participant data (IPD) available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing chest physiotherapy in people with Preterm Birth and Premature, run by Sanko University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

heart rate (time frame: Before starting chest physiotherapy and up to15 minutes after ending therapy). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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