Reflex Rolling Versus Lung Squeezing Techniques On Pulmon... | NCT06706128

Studies
Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia

NCT06706128

Sponsor

Delta University for Science and Technology

Status

Completed

Last Update Posted

Nov 26, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Pneumonia

Interventions

reflex rolling technique
lung squeezing technique

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Sep 15, 2024Actual

First Submitted Date

Nov 23, 2024

First Submission Date that Met QC Criteria

Nov 23, 2024

First Posted Date

Nov 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2024

Last Update Posted Date

Nov 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group (A)	Active Comparator	Consisted of twelve Preterm neonates	Other: reflex rolling technique
Group (B)	Active Comparator	Consisted of twelve Preterm neonates	Other: lung squeezing technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reflex rolling technique	Other	received reflex rolling technique for 20 min, 5 days a week, for 2 weeks.	Group (A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Rate	Detected using monitors (Hunt Leigh Healthcare /United Kingdom).	Respiratory Rate measured at day (0) at after 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Days

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Delta University for Science and Technology		Gamasa	Dakahelia	35712	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided