PneumoniaNCT05781464
Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates
A study testing Traditional chest physiotherapy and Prolonged slow expiration technique in people with Pneumonia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Traditional chest physiotherapy and Prolonged slow expiration technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Traditional chest physiotherapy, Prolonged slow expiration technique
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional chest physiotherapyProcedure or surgery
Also called Postural drainage, Percussion, Vibration, Foreo Vibrator
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).
Prolonged slow expiration techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional chest physiotherapy | Placebo comparator | 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 Receives: Procedure: Traditional chest physiotherapy |
| Prolonged slow expiration technique and traditional chest physiotherapy | Active comparator | 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. Receives: Procedure: Traditional chest physiotherapy; Procedure: Prolonged slow expiration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial oxygen saturation (Sao2)
Arterial oxygen saturation is assessed by standardized international monitor and measured by %
Measured: 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)
Measured: 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)
Measured: Change from baseline HR at 9 days
Change in temperature
Temperature is assessed by thermometer and measured by degree(°)
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline HCO3 at 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Apr 2023
- Primary completion3 Aug 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira Mohamed Metwally, Cairo University
- Investigators
- Elham Salem, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781464
- Sponsor's protocol ID
- NoP.T.REC/012/003676
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34568241Gomes 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.
PubMed 22499404
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia
- ClinicalTrials.gov ID
- NCT05781464
- Acronym / sponsor ID
- NoP.T.REC/012/003676
- Conditions
- Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional chest physiotherapy | Placebo comparator | Procedure: Traditional chest physiotherapyThis 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 |
| Prolonged slow expiration technique and traditional chest physiotherapy | Active comparator | Procedure: Traditional chest physiotherapy, Procedure: Prolonged slow expiration techniqueThis 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. |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional chest physiotherapyAlso: Postural drainage, Percussion, Vibration, Foreo VibratorPostural 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). | Procedure or surgery | Prolonged slow expiration technique and traditional chest physiotherapy, Traditional chest physiotherapy |
| Prolonged slow expiration techniqueThe 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. | Procedure or surgery | Prolonged slow expiration technique and traditional chest physiotherapy |
Primary outcome
Change in arterial oxygen saturation (Sao2)
Time frame: Change from Baseline SaO2 at 9 days
Arterial oxygen saturation is assessed by standardized international monitor and measured by %
Change in systolic and diastolic blood pressure
Time frame: Change from baseline systolic and diastolic blood pressure at 9 days
Systolic and diastolic blood pressure are assessed by standardized international monitor and measured by millimeters of mercury ( mmHg)
Change in heart rate (HR)
Time frame: Change from baseline HR at 9 days
Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM)
Change in temperature
Time frame: Change from baseline temperature at 9 days
Temperature is assessed by thermometer and measured by degree(°)
Change in power of hydrogen (PH)
Time frame: Change from baseline PH at 9 days
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)
Time frame: Change from baseline PaCO2 at 9 days
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)
Time frame: Change from baseline HCO3 at 9 days
HCO3 is assessed by blood gases machine and measured by milliequivalents per litre (mEq/L) and it is used to detect electrolyte imbalance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 34568241Lievens 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.
- Background: PubMed 22499404Gomes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Salem study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional chest physiotherapy and Prolonged slow expiration technique in people with Pneumonia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial oxygen saturation (Sao2) (time frame: Change from Baseline SaO2 at 9 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781464, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.