Respiratory Distress SyndromeRDSNCT06992492
Vojta Reflex Versus Lung Squeezing Technique in Respiratory Distress Preterm Neonate
A study testing vojta therapy +conventional chest physical therapy, lung squeezing technique +conventional chest physical therapy and conventional chest physical therapy in people with Respiratory Distress Syndrome, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
The goal of this clinical trial study is to find out the difference in the effect of vojta therapy and lung squeezing technique on preterm neonate with respiratory distress syndrome, to investigate the effect of vojta therapy and lung squeezing technique on Oxygen saturation and Respiratory rate, to evaluate the… Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- vojta therapy +conventional chest physical therapy, lung squeezing technique +conventional chest physical therapy and conventional chest physical therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 27 May 2025to 8 Oct 2025
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm neonates will be:
- Ranging from 28-36 weeks of gestation admitted to NICU with diagnosis of respiratory distress syndrome (RDS)on oxygen therapy.
- Medically free from any other diseases except RDS.
- On CPAP for respiratory support.
Who cannot join
- Preterm neonates who meet one of the following criteria will be excluded:
- Musculoskeletal disorders
- Encephalopathy
- Recent surgery
- Neonates with respiratory and cardiac congenital anomalies
- mechanically ventilated
Show all 12Show fewer
- genetic syndromes
- segmental or lobar collapse confirmed on chest X-ray
- congenital malformation
- asphyxia at birth
- treatment with neurotrophic drugs
- intraventricular hemorrhage < 2 grade
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni-Suef university hospitals
Banī Suwayf
Beni_Suef university
Banī Suwayf
About this study
Official title: Vojta Reflex Versus Lung Squeezing Technique In Preterm Neonate With Respiratory Distress Syndrome
The goal of this clinical trial study is to find out the difference in the effect of vojta therapy and lung squeezing technique on preterm neonate with respiratory distress syndrome, to investigate the effect of vojta therapy and lung squeezing technique on Oxygen saturation and Respiratory rate, to evaluate the effect of vojta therapy and lung squeezing technique on (The length of hospital stay, Silverman Anderson score, Downe's score for respiratory distress syndrome (RDS) in preterm neonate. The main question it aims to answer is:
Is There a significant difference in the effect of vojta therapy and lung squeezing technique in preterm neonate with respiratory distress syndrome. Researchers will compare effect of vojta therapy and lung squeezing technique and control group. neonates diagnosed with respiratory distress syndrome aged from 28 to 36 weeks will be recruited for this study for three weeks from neonate intensive care unit.
neonates will receive conventional chest physical therapy for the control group and convetional chest physical therapy plus vojta therapy or lung squeezing technique for the two other groups twice daily for three weeks.
Read the detailed description
Type of study: randomized clinical trial. this study is a prospective interventional study one that will be conducted on 90 preterm neonates of both sexes from Neonatal Intensive care unit in Beni-Suef university, their gestational age ranged from 28 to 36 weeks and randomly divided into 3 equal groups:
- study group (A) include preterm neonates with respiratory distress syndrome will receive vojta therapy along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
- study group (B) include preterm neonates with respiratory distress syndrome will receive lung squeezing technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
- control group (C) include preterm neonates with respiratory distress syndrome will receive conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment only with special emphasis on whether Surfactant therapy is given or not.
Measurement procedures:
1.) Oxygen saturation and Respiratory rate: For the three study groups, the SpO2 and respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, during each of the twice daily treatments. Throughout the whole procedure, the NBs were continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 < 90) which would indicate suspension of the technique. physiotherapist followed the infants for three weeks.
Study variables: 1)RR = assessed by clinical evaluation of chest movement in one minute and SpO2 = measured with a pulse oximeter.
- Silverman Anderson score: The Silverman Andersen Respiratory Severity Score (RSS) evaluates five parameters of work of breathing and assigns an overall score with a patient breathing comfortably a "0" and a patient in severe respiratory distress a "10".
Score 0-3 = Mild respiratory distress - O2 by hood Score 4-6 = Moderate respiratory distress - CPAP Score > 6 = Impending respiratory failure
- Downe's score for RDS: Downe score is an objective method to assess the severity of respiratory distress in newborns. It includes respiratory rate (RR), recessions, grunt, air entry and fractional oxygen requirement. Each parameter is score on a scale of 0, 1 and 2 with increasing severity. Total score ranges from 0 to 10.Score:
- <4 = follow up.
- 4-7 = clinical respiratory distress; monitor arterial blood gases.
- 7 = respiratory failure
- Conditions
- Respiratory Distress Syndrome
- Being tested
- vojta therapy +conventional chest physical therapy, lung squeezing technique +conventional chest physical therapy, conventional chest physical therapy
- Keywords
- RDS, preterm neonates
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vojta therapy +conventional chest physical therapyProcedure or surgery
infants will receive reflex rolling technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. This maneuver includes a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface. A digit pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. Each treatment consists in delivering four stimuli, two to the left half of the chest (stimulations I and II) and two to the right half of the chest (stimulations III and IV). Each stimulus will be consisted of slight pressure, progressively oriented in dorsal, medial and cranial direct
lung squeezing technique +conventional chest physical therapyProcedure or surgery
infants will receive lung squeezing technique along with conventional chest physiotherapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. Lung squeeze technique consists of 3- cumulative chest compressions lasting for 5 seconds, followed by a gentle low "release phase", with the chest wall completely released; the second compressions are performed successively for5 minutes on one hemithorax, then 5 minutes on the other hemi thorax. The infant will be in supine position, and without body tilt, for a total of 10 minutes. Use both hands to perform the squeeze on one hemithorax at one time. Place One hand on the posterolateral aspect of the hemi thorax and the other hand covered the anterior chest extending from the lower ribs to above the clavicle of the infant.
conventional chest physical therapyProcedure or surgery
Conventional Chest Physical Therapy will be given for both the groups A and B and for group C in isolation manner with medical treatment with special emphasis on whether Surfactant therapy is given or not.it includes postural drainage, vibration, and percussion. Postural drainage will be applied to infants by elevating head of the infant at 30 degrees to prevent gastro esophageal reflex and aspiration. In neonates and infants 'tenting' (using the first three or four fingers of one hand with slight elevation of the middle finger). Chest percussion will be given with motion from the wrist. Vibration of the chest will be done manually by placing the fingers on the chest wall over the segment being drained and the wrist and the elbow remained immobile, isometrically contracting the muscles of the forearm and hand to cause a vibratory motion. The procedure will be performed for 5min. Chest percussion position lying down on the right side and on the left, with 5 min duration on each side
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Group A infants will receive reflex rolling technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. This maneuver includes a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface. A digit pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. Each treatment consists in delivering four stimuli, two to the left half of the chest (stimulations I and II) and two to the right half of the chest (stimulations III and IV). Each stimulus will be consisted of slight pressure, progressively oriented in dorsal, medial and crani Receives: Procedure: vojta therapy +conventional chest physical therapy |
| group B | Active comparator | Group B infants will receive lung squeezing technique along with conventional chest physiotherapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. Lung squeeze technique consists of 3- cumulative chest compressions lasting for 5 seconds, followed by a gentle low "release phase", with the chest wall completely released; the second compressions are performed successively for5 minutes on one hemithorax, then 5 minutes on the other hemi thorax. The infant will be in supine position, and without body tilt, for a total of 10 minutes. Use both hands to perform the squeeze on one hemithorax at one time. Place One hand on the posterolateral aspect of the hemi thorax and the other hand covered the anterior chest extending from the lower ribs to above the clavicle of the infant Receives: Procedure: lung squeezing technique +conventional chest physical therapy |
| group C | Active comparator | Conventional Chest Physical Therapy will be given for both the groups A and B and for group C in isolation manner with medical treatment with special emphasis on whether Surfactant therapy is given or not.it includes postural drainage, vibration, and percussion. Postural drainage will be applied to infants by elevating head of the infant at 30 degrees to prevent gastro esophageal reflex and aspiration. In neonates and infants 'tenting' (using the first three or four fingers of one hand with slight elevation of the middle finger). Chest percussion will be given with motion from the wrist. Vibration of the chest will be done manually by placing the fingers on the chest wall over the segment being drained and the wrist and the elbow remained immobile, isometrically contracting the muscles of the forearm and hand to cause a vibratory motion. The procedure will be performed for 5min. Chest percussion position lying down on the right side and on the left, with 5 min duration on each sid Receives: Procedure: conventional chest physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
Oxygen saturation (SpO2) will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, twice daily. Throughout the whole procedure, oxygen saturation will be continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 < 90), which would indicate suspension of the technique. physiotherapist will follow the infants for three weeks.
Measured: from enrollment for three weeks twice daily
respiratory rate
respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, twice daily. Throughout the whole procedure, the respiratory rate will be continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect which would indicate suspension of the technique. physiotherapist will follow the infants for three weeks.
Measured: from enrollment for three weeks twice daily
Secondary outcomes (4)
Silverman Anderson score
The Silverman Andersen Respiratory Severity Score (RSS) evaluates five parameters of work of breathing and assigns an overall score with a patient breathing comfortably a "0" and a patient in severe respiratory distress a "10".
Score 0-3 = Mild respiratory distress - O2 by hood Score 4-6 = Moderate respiratory distress - CPAP Score > 6 = Impending respiratory failure
Measured: at the start of the study and after the intervention once day for three weeks
Downe's score for RDS
Downe score is an objective method to assess the severity of respiratory distress in newborns. It includes respiratory rate (RR), recessions, grunt, air entry and fractional oxygen requirement. Each parameter is score on a scale of 0, 1 and 2 with increasing severity. Total score ranges from 0 to 10.
Score:
- <4 = follow up.
- 4-7 = clinical respiratory distress; monitor arterial blood gases.
- 7 = respiratory failure
Measured: at the start of the study and after the intervention once day for three weeks
heart rate
heart rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, twice daily. Throughout the whole procedure, the heart rate will be continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect which would indicate suspension of the technique. physiotherapist will follow the infants for three weeks
Measured: from enrollment for three weeks twice daily
Arterial Blood Gas (ABG)
Arterial blood samples were collected once daily under aseptic conditions and sent to the laboratory. Parameters assessed included: pH (acid-base balance)PaO₂ (arterial oxygen tension, mmHg)PaCO₂ (arterial carbon dioxide tension, mmHg)HCO₃- (bicarbonate concentration, mmol/L)physiotherapist will follow the infants for three weeks.
Measured: from enrollment for three weeks once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start27 May 2025
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman mustafa mohammed elsagheer, Beni-Suef University
- Investigators
- Sherine H Mehani, professor, Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992492
- Sponsor's protocol ID
- FPTBSUREC/0905/2325
- Acronym
- RDS
- Status last verified
- Dec 2025
- First submitted
- 5 May 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vojta Reflex Versus Lung Squeezing Technique In Preterm Neonate With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06992492
- Acronym / sponsor ID
- RDS / FPTBSUREC/0905/2325
- Conditions
- Respiratory Distress Syndrome
- Keywords
- RDS, preterm neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 28 May 2025 (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.
The goal of this clinical trial study is to find out the difference in the effect of vojta therapy and lung squeezing technique on preterm neonate with respiratory distress syndrome, to investigate the effect of vojta therapy and lung squeezing technique on Oxygen saturation and Respiratory rate, to evaluate the effect of vojta therapy and lung squeezing technique on (The length of hospital stay, Silverman Anderson score, Downe's score for respiratory distress syndrome (RDS) in preterm neonate. The main question it aims to answer is:
Is There a significant difference in the effect of vojta therapy and lung squeezing technique in preterm neonate with respiratory distress syndrome. Researchers will compare effect of vojta therapy and lung squeezing technique and control group. neonates diagnosed with respiratory distress syndrome aged from 28 to 36 weeks will be recruited for this study for three weeks from neonate intensive care unit.
neonates will receive conventional chest physical therapy for the control group and convetional chest physical therapy plus vojta therapy or lung squeezing technique for the two other groups twice daily for three weeks.
Detailed description
Type of study: randomized clinical trial. this study is a prospective interventional study one that will be conducted on 90 preterm neonates of both sexes from Neonatal Intensive care unit in Beni-Suef university, their gestational age ranged from 28 to 36 weeks and randomly divided into 3 equal groups:
- study group (A) include preterm neonates with respiratory distress syndrome will receive vojta therapy along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
- study group (B) include preterm neonates with respiratory distress syndrome will receive lung squeezing technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not.
- control group (C) include preterm neonates with respiratory distress syndrome will receive conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment only with special emphasis on whether Surfactant therapy is given or not.
Measurement procedures:
1.) Oxygen saturation and Respiratory rate: For the three study groups, the SpO2 and respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, during each of the twice daily treatments. Throughout the whole procedure, the NBs were continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 < 90) which would indicate suspension of the technique. physiotherapist followed the infants for three weeks.
Study variables: 1)RR = assessed by clinical evaluation of chest movement in one minute and SpO2 = measured with a pulse oximeter.
- Silverman Anderson score: The Silverman Andersen Respiratory Severity Score (RSS) evaluates five parameters of work of breathing and assigns an overall score with a patient breathing comfortably a "0" and a patient in severe respiratory distress a "10".
Score 0-3 = Mild respiratory distress - O2 by hood Score 4-6 = Moderate respiratory distress - CPAP Score > 6 = Impending respiratory failure
- Downe's score for RDS: Downe score is an objective method to assess the severity of respiratory distress in newborns. It includes respiratory rate (RR), recessions, grunt, air entry and fractional oxygen requirement. Each parameter is score on a scale of 0, 1 and 2 with increasing severity. Total score ranges from 0 to 10.Score:
- <4 = follow up.
- 4-7 = clinical respiratory distress; monitor arterial blood gases.
- 7 = respiratory failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: vojta therapy +conventional chest physical therapyGroup A infants will receive reflex rolling technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. This maneuver includes a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface. A digit pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. Each treatment consists in delivering four stimuli, two to the left half of the chest (stimulations I and II) and two to the right half of the chest (stimulations III and IV). Each stimulus will be consisted of slight pressure, progressively oriented in dorsal, medial and crani |
| group B | Active comparator | Procedure: lung squeezing technique +conventional chest physical therapyGroup B infants will receive lung squeezing technique along with conventional chest physiotherapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. Lung squeeze technique consists of 3- cumulative chest compressions lasting for 5 seconds, followed by a gentle low "release phase", with the chest wall completely released; the second compressions are performed successively for5 minutes on one hemithorax, then 5 minutes on the other hemi thorax. The infant will be in supine position, and without body tilt, for a total of 10 minutes. Use both hands to perform the squeeze on one hemithorax at one time. Place One hand on the posterolateral aspect of the hemi thorax and the other hand covered the anterior chest extending from the lower ribs to above the clavicle of the infant |
| group C | Active comparator | Procedure: conventional chest physical therapyConventional Chest Physical Therapy will be given for both the groups A and B and for group C in isolation manner with medical treatment with special emphasis on whether Surfactant therapy is given or not.it includes postural drainage, vibration, and percussion. Postural drainage will be applied to infants by elevating head of the infant at 30 degrees to prevent gastro esophageal reflex and aspiration. In neonates and infants 'tenting' (using the first three or four fingers of one hand with slight elevation of the middle finger). Chest percussion will be given with motion from the wrist. Vibration of the chest will be done manually by placing the fingers on the chest wall over the segment being drained and the wrist and the elbow remained immobile, isometrically contracting the muscles of the forearm and hand to cause a vibratory motion. The procedure will be performed for 5min. Chest percussion position lying down on the right side and on the left, with 5 min duration on each sid |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- preterm neonates will be:
Key exclusion criteria (12 listed)
- Preterm neonates who meet one of the following criteria will be excluded:
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 |
|---|---|---|
| vojta therapy +conventional chest physical therapyinfants will receive reflex rolling technique along with conventional chest physical therapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. This maneuver includes a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface. A digit pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. Each treatment consists in delivering four stimuli, two to the left half of the chest (stimulations I and II) and two to the right half of the chest (stimulations III and IV). Each stimulus will be consisted of slight pressure, progressively oriented in dorsal, medial and cranial direct | Procedure or surgery | group A |
| lung squeezing technique +conventional chest physical therapyinfants will receive lung squeezing technique along with conventional chest physiotherapy (postural drainage, percussion and vibration) plus medical treatment with special emphasis on whether Surfactant therapy is given or not. Lung squeeze technique consists of 3- cumulative chest compressions lasting for 5 seconds, followed by a gentle low "release phase", with the chest wall completely released; the second compressions are performed successively for5 minutes on one hemithorax, then 5 minutes on the other hemi thorax. The infant will be in supine position, and without body tilt, for a total of 10 minutes. Use both hands to perform the squeeze on one hemithorax at one time. Place One hand on the posterolateral aspect of the hemi thorax and the other hand covered the anterior chest extending from the lower ribs to above the clavicle of the infant. | Procedure or surgery | group B |
| conventional chest physical therapyConventional Chest Physical Therapy will be given for both the groups A and B and for group C in isolation manner with medical treatment with special emphasis on whether Surfactant therapy is given or not.it includes postural drainage, vibration, and percussion. Postural drainage will be applied to infants by elevating head of the infant at 30 degrees to prevent gastro esophageal reflex and aspiration. In neonates and infants 'tenting' (using the first three or four fingers of one hand with slight elevation of the middle finger). Chest percussion will be given with motion from the wrist. Vibration of the chest will be done manually by placing the fingers on the chest wall over the segment being drained and the wrist and the elbow remained immobile, isometrically contracting the muscles of the forearm and hand to cause a vibratory motion. The procedure will be performed for 5min. Chest percussion position lying down on the right side and on the left, with 5 min duration on each side | Procedure or surgery | group C |
Primary outcome
Oxygen saturation
Time frame: from enrollment for three weeks twice daily
Oxygen saturation (SpO2) will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, twice daily. Throughout the whole procedure, oxygen saturation will be continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect, including hypoxemia (SpO2 < 90), which would indicate suspension of the technique. physiotherapist will follow the infants for three weeks.
respiratory rate
Time frame: from enrollment for three weeks twice daily
respiratory rate will be measured and noted before the reflex stimulation, at the end of stimulation II, at the end of stimulation IV and at 5, 15, 25 minutes after the whole series of stimulations, twice daily. Throughout the whole procedure, the respiratory rate will be continuously monitored with a Vismo PVM-2701 monitor to assess any adverse effect which would indicate suspension of the technique. physiotherapist will follow the infants for three weeks.
4 secondary outcomes
Silverman Anderson score
Time frame: at the start of the study and after the intervention once day for three weeks
Downe's score for RDS
Time frame: at the start of the study and after the intervention once day for three weeks
heart rate
Time frame: from enrollment for three weeks twice daily
Arterial Blood Gas (ABG)
Time frame: from enrollment for three weeks once daily
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sherine H Mehani, professor study director
Beni-Suef University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vojta therapy +conventional chest physical therapy, lung squeezing technique +conventional chest physical therapy and conventional chest physical therapy in people with Respiratory Distress Syndrome, run by Beni-Suef University at 2 sites 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 12 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Oxygen saturation (time frame: from enrollment for three weeks twice daily). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.