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

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

heart rate

Secondary Outcome

 Chest shape and type (barrel/pektusexcavatum..etc)

Condition

Preterm Birth

Intervention

chest physiotherapy

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

September 30, 2021

Completion Date

December 1, 2021

Primary Completion Date

November 1, 2021

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
      

Gender

All

Ages

N/A - 45 Days

Accepts Healthy Volunteers

No

Contacts

hatice Adiguzel, PhD, +90 505 649 10 48, [email protected]



Administrative Informations


NCT ID

NCT05036603

Organization ID

FTR


Responsible Party

Principal Investigator

Study Sponsor

Sanko University


Study Sponsor

hatice Adiguzel, PhD, Principal Investigator, Kahramanmaras Sutcu Imam University


Verification Date

September 2021