NCT07579013

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Oct 2025Aug 2026

Study Start

First participant enrolled

October 28, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

RDS, Postural drainage, Thoracic squeezing, O2

Outcome Measures

Primary Outcomes (1)

  • 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).

    BASE LINE, 4 WEEKS

Secondary Outcomes (1)

  • ANDERSON Scale

    BASE LINE, 4 WEEKS

Study Arms (2)

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).

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.

Other: POSTURAL DRAINAGE TECHNIQUE

Interventions

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.

Also known as: Thoracic Squeezing Technique
ANDERSON Scale.Oxygenation levels

Eligibility Criteria

Age1 Month - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ● Children diagnosed with RDS.
  • Pre term infants. Birth history with c- section.
  • No congenital malformation.

You may not qualify if:

  • ● Under treatment with neurotropic drugs.
  • Respiratory and cardiac congenital anamolies.
  • Genetic disorder.
  • Interventricular hemorrhage or seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • NIMRA MUBASHAR, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD ASIF JAVED, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
PARTICIPANTS WILL GET SEPARTAE TREATMENT PROTOCOLS, AND POSSIBLE EFFORTS WILL BE PUT TO MASK BOTH GROUPS ABOUT THE TREATMENT.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

October 28, 2025

Primary Completion (Estimated)

July 5, 2026

Study Completion (Estimated)

August 6, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations