Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05036603
Other study ID # FTR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date August 15, 2022

Study information

Verified date August 2022
Source Sanko University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 15, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Day to 45 Days
Eligibility 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 Design


Intervention

Other:
chest physiotherapy
diffferent chest physiotherapy methods

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary heart rate heart rate of the preterm newborns Before starting chest physiotherapy and up to15 minutes after ending therapy
Primary 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
Primary 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
Primary PaO2 PaO2 of the preterm newborns on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Primary blood pressure blood pressure of the preterm newborns on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Primary respiratory rate respiratory rate of the preterm newborns Before starting chest physiotherapy and up to15 minutes after ending therapy
Primary 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
Primary Pip (cm H2O) Pip (cm H2O) of the preterm newborns on the time before starting chest physiotherapy and up to15 minutes after ending therapy
Primary FIO2 (%/mm Hg) FIO2 (%/mm Hg) of the preterm newborns on the time before starting chest physiotherapy and up to 15 minutes after ending therapy
Primary 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 Chest shape and type (barrel/pektusexcavatum..etc) 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
Secondary 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). before physiotherapy
Secondary the respiratory pattern 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
Secondary Daily nutrition type 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04811742 - Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn N/A