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

NCT05036603 | Completed

• 1 other identifier: FTR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• heart rate

  heart rate of the preterm newborns

  Before starting chest physiotherapy and up to15 minutes after ending therapy

• 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

• 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

• PaO₂

  PaO₂ of the preterm newborns

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

• blood pressure

  blood pressure of the preterm newborns

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

• respiratory rate

  respiratory rate of the preterm newborns

  Before starting chest physiotherapy and up to15 minutes after ending therapy

• 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

• Pip (cm H₂O)

  Pip (cm H₂O) of the preterm newborns

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

• FİO₂ (%/mm Hg)

  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)

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

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

Secondary Outcomes (4)

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

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

• Respiratory stress

  before physiotherapy

• the respiratory pattern

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

• Daily nutrition type

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

Study Arms (3)

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

NO INTERVENTION

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.

2/active chest physiotherapy in modified drainage positions

EXPERIMENTAL

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

3/active chest physiotherapy in prone positions

EXPERIMENTAL

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

Interventions

chest physiotherapy OTHER

diffferent chest physiotherapy methods

2/active chest physiotherapy in modified drainage positions; 3/active chest physiotherapy in prone positions

Eligibility Criteria

• Age: 1 Day - 45 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome; Pulmonary Atelectasis; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Distress Syndrome, Newborn

Study Officials

• hatice Adiguzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: 2 groups; different chest physitherapy approach and 1 grup(control): routine medical care for newborns and neonatal intensive care unit's routin daily care

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 5, 2021
• Study Start: April 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 15, 2024
• Last Updated: September 12, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)