Respiratory Distress SyndromeNCT07579013
Effect of Postural Drainage With or Without Thoracic Squeezing on O2 and Respiratory Rate in Infant With RDS.
A study testing POSTURAL DRAINAGE TECHNIQUE in people with Respiratory Distress Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study investigated whether adding thoracic squeezing to postural drainage improves immediate respiratory outcomes in preterm infants with Respiratory Distress Syndrome (RDS). Over nine months, 14 preterm infants (all born via cesarean section) were randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 1 month to 2 months
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- POSTURAL DRAINAGE TECHNIQUE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2025to 26 Jul 2026
- 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 month to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ● Children diagnosed with RDS.
- Pre term infants. Birth history with c- section.
- No congenital malformation.
Who cannot join
- ● Under treatment with neurotropic drugs.
- Respiratory and cardiac congenital anamolies.
- Genetic disorder.
- Interventricular hemorrhage or seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Postural Drainage With or Without Thoracic Squeezing on Oxygen Saturation and Respiratory Rate in Children With Respiratory Distress Syndrome.
This study investigated whether adding thoracic squeezing to postural drainage improves immediate respiratory outcomes in preterm infants with Respiratory Distress Syndrome (RDS).
Over nine months, 14 preterm infants (all born via cesarean section) were randomly assigned to two groups. The control group received standard care with postural drainage, while the experimental group received postural drainage combined with the lung squeezing technique (LST), which applies gentle chest pressure to enhance airflow and mucus clearance. Infants with genetic disorders, congenital anomalies, or on neurotropic drugs were excluded.
Read more
Oxygen saturation and respiratory distress were measured using the Oxygen Saturation Index and Silverman-Anderson Scale, with data analyzed in SPSS.
The study aimed to determine whether combining thoracic squeezing with postural drainage has a greater immediate effect on improving oxygen levels and reducing respiratory distress compared to postural drainage alone.
Read the detailed description
Respiratory distress syndrome (RDS) is a common respiratory condition affecting preterm infants, characterized by insufficient lung function leading to impaired oxygenation and increased respiratory effort. Physiotherapy interventions like postural drainage are often used to improve lung clearance and respiratory status. However, the effectiveness of combining postural drainage with thoracic squeezing on immediate respiratory outcomes remains unclear. The lung squeezing technique (LST), an advanced form of chest physiotherapy, involves applying gentle, sustained pressure to the chest wall, followed by a full release. This process helps elevate intrathoracic pressure, which can activate the cough reflex, aid in the movement of mucus, promote deeper inhalation, and enhance ventilation within the alveoli. The objective of the study is aimed to evaluate the immediate effects of postural drainage with or without thoracic squeezing on oxygen saturation and respiratory rate in children with RDS.
This study was conducted over nine months at AMTH and HLTH settings, enrolling a total of 14 preterm infants with a history of cesarean section birth. Participants were selected using the Epi tool for sample size calculation and randomized into two groups: the control group received standard care involving postural training, while the experimental group underwent postural drainage combined with thoracic squeezing techniques. Exclusion criteria included infants under treatment with neurotropic drugs, those diagnosed with genetic disorders, and those presenting with congenital cardiac or respiratory anomalies. Data collection employed the Oxygen Saturation Index to measure oxygen levels and the Silverman-Anderson Scale to assess respiratory distress. Collected data were analyzed using SPSS software to determine the effects of the interventions on oxygen saturation and respiratory rate.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- POSTURAL DRAINAGE TECHNIQUE
- Keywords
- RDS, Postural drainage, Thoracic squeezing, O2
- 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.
POSTURAL DRAINAGE TECHNIQUEOther
Also called Thoracic Squeezing Technique
A structured chest physiotherapy protocol will be applied in neonates to enhance airway clearance by targeting specific lung segments. This includes appropriate positioning-supine for upper lobes and side-lying for lower lobes-combined with gentle chest percussion to mobilize secretions while avoiding sensitive areas. Sessions last 4-5 minutes and are repeated every 3 hours, with careful monitoring of vital signs and precautions such as avoiding treatment soon after feeding. Additionally, the thoracic squeezing technique is used to simulate a cough by applying gentle, rhythmic compressions during expiration in a side-lying position. Performed for about 10 minutes on each side after drainage or percussion, it helps move secretions toward central airways, particularly in infants with weak cough reflexes, with continuous monitoring to ensure safety and immediate cessation if distress occurs.
| Study group | Role | What they receive |
|---|---|---|
| Oxygenation levels | Experimental | Evaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible.
The Oxygen Saturation Index (OSI) is determined using the formula:
(FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14). Receives: Other: POSTURAL DRAINAGE TECHNIQUE |
| ANDERSON Scale. | Experimental | The Silverman-Anderson scores are widely used clinical tools designed to evaluate the severity of respiratory distress in newborns. Both systems rely on objective clinical parameters to quantify respiratory difficulty. The Silverman-Anderson score specifically measures five key signs: chest retractions in the upper and lower thorax, subxiphoid retraction, nasal flaring, and audible grunting during exhalation. Each of these indicators is rated on a scale from 0 to 2, allowing healthcare providers to systematically assess and monitor the progression or improvement of respiratory distress in neonates. Receives: Other: POSTURAL DRAINAGE TECHNIQUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation levels
Evaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible.
The Oxygen Saturation Index (OSI) is determined using the formula:
(FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14).
Measured: BASE LINE, 4 WEEKS
Secondary outcomes (1)
ANDERSON Scale
The Silverman-Anderson scores are widely used clinical tools designed to evaluate the severity of respiratory distress in newborns. Both systems rely on objective clinical parameters to quantify respiratory difficulty. The Silverman-Anderson score specifically measures five key signs: chest retractions in the upper and lower thorax, subxiphoid retraction, nasal flaring, and audible grunting during exhalation. Each of these indicators is rated on a scale from 0 to 2, allowing healthcare providers to systematically assess and monitor the progression or improvement of respiratory distress in neonates.
Measured: BASE LINE, 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start28 Oct 2025
- Primary completion5 Jul 2026
- Study completion26 Jul 2026
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NIMRA MUBASHAR, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579013
- Sponsor's protocol ID
- REC/RCR&AHS/25/0737
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Postural Drainage With or Without Thoracic Squeezing on Oxygen Saturation and Respiratory Rate in Children With Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT07579013
- Acronym / sponsor ID
- REC/RCR&AHS/25/0737
- Conditions
- Respiratory Distress Syndrome
- Keywords
- RDS, Postural drainage, Thoracic squeezing, O2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 26 Jul 2026 (actual)
- First posted
- 11 May 2026 (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.
This study investigated whether adding thoracic squeezing to postural drainage improves immediate respiratory outcomes in preterm infants with Respiratory Distress Syndrome (RDS).
Over nine months, 14 preterm infants (all born via cesarean section) were randomly assigned to two groups. The control group received standard care with postural drainage, while the experimental group received postural drainage combined with the lung squeezing technique (LST), which applies gentle chest pressure to enhance airflow and mucus clearance. Infants with genetic disorders, congenital anomalies, or on neurotropic drugs were excluded.
Oxygen saturation and respiratory distress were measured using the Oxygen Saturation Index and Silverman-Anderson Scale, with data analyzed in SPSS.
The study aimed to determine whether combining thoracic squeezing with postural drainage has a greater immediate effect on improving oxygen levels and reducing respiratory distress compared to postural drainage alone.
Detailed description
Respiratory distress syndrome (RDS) is a common respiratory condition affecting preterm infants, characterized by insufficient lung function leading to impaired oxygenation and increased respiratory effort. Physiotherapy interventions like postural drainage are often used to improve lung clearance and respiratory status. However, the effectiveness of combining postural drainage with thoracic squeezing on immediate respiratory outcomes remains unclear. The lung squeezing technique (LST), an advanced form of chest physiotherapy, involves applying gentle, sustained pressure to the chest wall, followed by a full release. This process helps elevate intrathoracic pressure, which can activate the cough reflex, aid in the movement of mucus, promote deeper inhalation, and enhance ventilation within the alveoli. The objective of the study is aimed to evaluate the immediate effects of postural drainage with or without thoracic squeezing on oxygen saturation and respiratory rate in children with RDS.
This study was conducted over nine months at AMTH and HLTH settings, enrolling a total of 14 preterm infants with a history of cesarean section birth. Participants were selected using the Epi tool for sample size calculation and randomized into two groups: the control group received standard care involving postural training, while the experimental group underwent postural drainage combined with thoracic squeezing techniques. Exclusion criteria included infants under treatment with neurotropic drugs, those diagnosed with genetic disorders, and those presenting with congenital cardiac or respiratory anomalies. Data collection employed the Oxygen Saturation Index to measure oxygen levels and the Silverman-Anderson Scale to assess respiratory distress. Collected data were analyzed using SPSS software to determine the effects of the interventions on oxygen saturation and respiratory rate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygenation levels | Experimental | Other: POSTURAL DRAINAGE TECHNIQUEEvaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible. The Oxygen Saturation Index (OSI) is determined using the formula: (FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14). |
| ANDERSON Scale. | Experimental | Other: POSTURAL DRAINAGE TECHNIQUEThe Silverman-Anderson scores are widely used clinical tools designed to evaluate the severity of respiratory distress in newborns. Both systems rely on objective clinical parameters to quantify respiratory difficulty. The Silverman-Anderson score specifically measures five key signs: chest retractions in the upper and lower thorax, subxiphoid retraction, nasal flaring, and audible grunting during exhalation. Each of these indicators is rated on a scale from 0 to 2, allowing healthcare providers to systematically assess and monitor the progression or improvement of respiratory distress in neonates. |
Who may qualify
- Ages
- 1 month to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ● Children diagnosed with RDS.
Key exclusion criteria (4 listed)
- ● Under treatment with neurotropic drugs.
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 |
|---|---|---|
| POSTURAL DRAINAGE TECHNIQUEAlso: Thoracic Squeezing TechniqueA structured chest physiotherapy protocol will be applied in neonates to enhance airway clearance by targeting specific lung segments. This includes appropriate positioning-supine for upper lobes and side-lying for lower lobes-combined with gentle chest percussion to mobilize secretions while avoiding sensitive areas. Sessions last 4-5 minutes and are repeated every 3 hours, with careful monitoring of vital signs and precautions such as avoiding treatment soon after feeding. Additionally, the thoracic squeezing technique is used to simulate a cough by applying gentle, rhythmic compressions during expiration in a side-lying position. Performed for about 10 minutes on each side after drainage or percussion, it helps move secretions toward central airways, particularly in infants with weak cough reflexes, with continuous monitoring to ensure safety and immediate cessation if distress occurs. | Other | ANDERSON Scale., Oxygenation levels |
Primary outcome
Oxygenation levels
Time frame: BASE LINE, 4 WEEKS
Evaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible. The Oxygen Saturation Index (OSI) is determined using the formula: (FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14).
1 secondary outcome
ANDERSON Scale
Time frame: BASE LINE, 4 WEEKS
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 30 Sep 2026.
- Effect of Thoracic Squeezing Technique and Expiratory Flow Increase Technique on Neonates With Neonatal Respiratory Distress Syndrome: A Case ReportLink provided by the sponsor.
- 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.
NIMRA MUBASHAR, MS-PT principal investigator
Riphah International 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 POSTURAL DRAINAGE TECHNIQUE in people with Respiratory Distress Syndrome, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 4 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 30 Sep 2026. 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 Pakistan. 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?
Oxygenation levels (time frame: BASE LINE, 4 WEEKS). 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 30 Sep 2026.