- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06706128
Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia
November 23, 2024 updated by: Delta University for Science and Technology
Respiratory problems in neonates are one of the leading causes of neonatal morbidity and mortality in developing countries.
These respiratory problems are seen in premature neonates, which mainly include respiratory distress syndrome (RDS), pneumonia, requiring ventilatory assistance or oxygen support
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare between the effect of reflex rolling and lung squeezing techniques on pulmonary functions in premature neonates with pneumonia.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahelia
-
Gamasa, Dakahelia, Egypt, 35712
- Delta University for Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1) Preterm neonates with pneumonia. 2) Neonates with 30-37 weeks of gestation admitted to NICU. 3) They were free from any major congenital malformation. 4) They were clinically and thermodynamically stable.
Exclusion Criteria:
- 1) Treatment with neurotropic drugs. 2) Interventricular hemorrhage. 3) Temperature >38 4) Respiratory and cardiac congenital anomalies. 5) Seizures. 6) Surgical procedures. 7) Genetic Disorders 8) Any segmental or lobar collapse confirmed on chest x-ray. 9) Major airway interventions including change of endo-tracheal tube, hand ventilation or bronchial lavage in the previous 12 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (A)
Consisted of twelve Preterm neonates
|
received reflex rolling technique for 20 min, 5 days a week, for 2 weeks.
|
|
Active Comparator: Group (B)
Consisted of twelve Preterm neonates
|
lung squeezing technique for 20 min, 5 days a week, for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Rate
Time Frame: Respiratory Rate measured at day (0) at after 2 weeks
|
Detected using monitors (Hunt Leigh Healthcare /United Kingdom).
|
Respiratory Rate measured at day (0) at after 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 15, 2024
Study Registration Dates
First Submitted
November 23, 2024
First Submitted That Met QC Criteria
November 23, 2024
First Posted (Estimated)
November 26, 2024
Study Record Updates
Last Update Posted (Estimated)
November 26, 2024
Last Update Submitted That Met QC Criteria
November 23, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pneumonia.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.