Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates

Study Overview
=================
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.

Official Title
-----------------
Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Procedure: Traditional chest physiotherapy
* Procedure: Prolonged slow expiration technique


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional chest physiotherapy<br>This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) in each session which is twice daily from admission to neonatal intensive care unit till discharge | Procedure: Traditional chest physiotherapy<br>* Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies. Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time. Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion. Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).<br>* Other names: Foreo Vibrator;|
| Active Comparator: Prolonged slow expiration technique and traditional chest physiotherapy<br>This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) plus prolonged slow expiration technique in each session which is twice daily from admission in neonatal intensive care unit till discharge. | Procedure: Traditional chest physiotherapy<br>* Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies. Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time. Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion. Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).<br>* Other names: Foreo Vibrator;Procedure: Prolonged slow expiration technique<br>* The therapist places one hand on the thorax below the suprasternal notch and the other hand over the upper abdomen while the neonate is supine. Both hands will have hypothenar contact with the thorax and abdomen. At the end of the expiratory phase, the therapist places a compression force with both hands. Compression at the end of expiration with hypothenar eminence is kept for 2 or 3 breathing cycles. This technique is repeated several times, with a rest time between applications of about 5 or 10 spontaneous breaths.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arterial oxygen saturation (Sao2) | Arterial oxygen saturation is assessed by standardized international monitor and measured by % | Change from Baseline SaO2 at 9 days | 
| Change in systolic and diastolic blood pressure | Systolic and diastolic blood pressure are assessed by standardized international monitor and measured by millimeters of mercury ( mmHg) | Change from baseline systolic and diastolic blood pressure at 9 days | 
| Change in heart rate (HR) | Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM) | Change from baseline HR at 9 days | 
| Change in temperature | Temperature is assessed by thermometer and measured by degree(°) | Change from baseline temperature at 9 days | 
| Change in power of hydrogen (PH) | PH is assessed by blood gases machine and it is a scale used to specify the acidity or basicity of blood | Change from baseline PH at 9 days | 
| Change in partial pressure of carbon dioxide (PaCO2) | PaCO2 is assessed by blood gases machine and measured by mmHg and it serves as a marker of sufficient alveolar ventilation within the lungs | Change from baseline PaCO2 at 9 days | 
| Change in bicarbonate (HCO3) | HCO3 is assessed by blood gases machine and measured by milliequivalents per litre (mEq/L) and it is used to detect electrolyte imbalance | Change from baseline HCO3 at 9 days |