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

Primary Purpose

Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional chest physiotherapy
Prolonged slow expiration technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

1 Day - 2 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Traditional chest physiotherapy

    Prolonged slow expiration technique and traditional chest physiotherapy

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Change in arterial oxygen saturation (Sao2)
    Arterial oxygen saturation is assessed by standardized international monitor and measured by %
    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 in heart rate (HR)
    Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM)
    Change in temperature
    Temperature is assessed by thermometer and measured by degree(°)
    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 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 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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05781464
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional chest physiotherapy
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    Prolonged slow expiration technique and traditional chest physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Traditional chest physiotherapy
    Other Intervention Name(s)
    Postural drainage, Percussion, Vibration, Foreo Vibrator
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Prolonged slow expiration technique
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in arterial oxygen saturation (Sao2)
    Description
    Arterial oxygen saturation is assessed by standardized international monitor and measured by %
    Time Frame
    Change from Baseline SaO2 at 9 days
    Title
    Change in systolic and diastolic blood pressure
    Description
    Systolic and diastolic blood pressure are assessed by standardized international monitor and measured by millimeters of mercury ( mmHg)
    Time Frame
    Change from baseline systolic and diastolic blood pressure at 9 days
    Title
    Change in heart rate (HR)
    Description
    Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM)
    Time Frame
    Change from baseline HR at 9 days
    Title
    Change in temperature
    Description
    Temperature is assessed by thermometer and measured by degree(°)
    Time Frame
    Change from baseline temperature at 9 days
    Title
    Change in power of hydrogen (PH)
    Description
    PH is assessed by blood gases machine and it is a scale used to specify the acidity or basicity of blood
    Time Frame
    Change from baseline PH at 9 days
    Title
    Change in partial pressure of carbon dioxide (PaCO2)
    Description
    PaCO2 is assessed by blood gases machine and measured by mmHg and it serves as a marker of sufficient alveolar ventilation within the lungs
    Time Frame
    Change from baseline PaCO2 at 9 days
    Title
    Change in bicarbonate (HCO3)
    Description
    HCO3 is assessed by blood gases machine and measured by milliequivalents per litre (mEq/L) and it is used to detect electrolyte imbalance
    Time Frame
    Change from baseline HCO3 at 9 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    2 Months
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moshira Metwally
    Phone
    +201114315193
    Email
    moshira708@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alaa El nemr
    Phone
    +201003727467
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elham El hadedy
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34568241
    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.
    Results Reference
    background
    PubMed Identifier
    22499404
    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.
    Results Reference
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    Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates

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