Clinical trial NCT05781464: Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates
Official title: Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pneumonia is a medical condition that, if not treated promptly, can lead to life- threatening complications. The prolonged slow expiration technique is a new type of chest physiotherapy that helps infants discharge bronchial secretions which accumulated due to pneumonia.

Detailed description: Pneumonia is an infective lung condition that is one of the most common risk factors for neonatal death. Pulmonary infections, most common caused by anaerobic bacterial infection, result in the accumulation of pus in the pleural cavity. Preterms, neonates with respiratory infections, and underdeveloped lungs all require the use of a prolonged slow expiration technique.

Prolonged slow expiration technique is the only chest clearance technique that provides both effective clearance and a soothing effect. Another recommendation for this technique is lack of application of emerging techniques of respiratory physiotherapy. Although the technique is effective, it is rarely in practice over the conventional methods of chest physiotherapy.

During prolonged slow expiration, intrathoracic pressure gradually rises due to thoracoabdominal compression, preventing bronchial collapse and flow disruption that occurs during forced expirations.

Eligibility criteria: Inclusion Criteria:

* Age since birth till 2 months
* Clinical findings of pneumonia: tachypnea, chest recession, fever, cyanosis and cough
* Radiological diagnosis of pneumonia (x-ray): lober or segmental consolidation, nodular or coarse patchy infiltration, diffuse haziness and air bronchogram.
* Neonates on oxygen therapy.

Exclusion Criteria:

* Neonates with congenital cardiopathy.
* Neonates with surgical incision in thorax or abdomen.
* Neonates with neurological intervention.
* Neonates with obstruction of upper air way.
* Neonates with gastroesophageal reflux and laryngeal affection.

Primary outcomes:
measure: Change in arterial oxygen saturation (Sao2)
timeFrame: Change from Baseline SaO2 at 9 days
measure: Change in systolic and diastolic blood pressure
timeFrame: Change from baseline systolic and diastolic blood pressure at 9 days
measure: Change in heart rate (HR)
timeFrame: Change from baseline HR at 9 days
measure: Change in temperature
timeFrame: Change from baseline temperature at 9 days
measure: Change in power of hydrogen (PH)
timeFrame: Change from baseline PH at 9 days
measure: Change in partial pressure of carbon dioxide (PaCO2)
timeFrame: Change from baseline PaCO2 at 9 days
measure: Change in bicarbonate (HCO3)
timeFrame: Change from baseline HCO3 at 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical Therapy
Study officials:
affiliation: Cairo University
name: Elham Salem
role: STUDY_CHAIR
References:
citation: Lievens L, Vandenplas Y, Vanlaethem S, Van Ginderdeuren F. Prolonged Slow Expiration Technique and Gastroesophageal Reflux in Infants Under the Age of 1 Year. Front Pediatr. 2021 Sep 8;9:722452. doi: 10.3389/fped.2021.722452. eCollection 2021.
citation: Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.