Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy

April 27, 2025 updated by: Elsayed Mehrem, Cairo University

Efficacy of Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit: A Clinical Trial Study

Hypoxic-ischemic encephalopathy (HIE) is a dangerous illness that happens when a newborn's brain does not receive adequate oxygen and blood flow, which can result in serious effects such as cerebral palsy and epilepsy. Infant diagnosed with HIE required ventilator support and subsequently developed pneumonia. They experienced respiratory problems and feeding challenges. Chest Physical Therapy is the best modalities to clear chest and improve ventilation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study to investigate the effect of chest physical therapy on Arterial Blood Gases for neonates post hypoxic ischemic encephalopathy (HIE) in Neonatal intensive care unit.

Methods: Fifty neonates from both sexes, age from birth to 10 days, post HIE with chest problems were selected from neonatal intensive care unit (NICU) at Minia University hospital, Egypt. They were divided into two equal groups, control group (CG) received traditional medical treatment according to American Academy of Pediatrics (AAP) recommendations and study group (SG) received traditional medical treatment plus Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration. The sessions will apply once daily for 6 days/week, each session is about 30 minutes, according to the neonate tolerance till complete clinical cure and discharge from NICU.

the outcome will measure by Timing of Arterial blood gases improvement, Duration required for clinical improvement, Duration of Mechanical ventilation, Duration of Hospitalization.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

  • Name: Elsayed Mehrem, Associate Professor
  • Phone Number: +201006973334
  • Email: sayed7555@yahoo.com

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:

  • Neonates with chest problems post Hypoxic-ischemic encephalopathy

Exclusion Criteria:

  • Neonates with chest problems due to other Causes except post Hypoxic-ischemic encephalopathy.
  • unstable medical status
  • Neonates with Post-operative s' respiratory problems due to any reasons.

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
Experimental: Chest physical Therapy group
Study group
Other: Chest Physical Therapy (CPT) modalities , Medical Treatment
Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.
Experimental: Medical treatment group
Control group
Other: Chest Physical Therapy (CPT) modalities , Medical Treatment
Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of Arterial blood gases improvement
Time Frame: 3-14 days
Time needed to improve Arterial blood gases due to CPT
3-14 days
Timing required for clinical improvement
Time Frame: 3-14 days
Time needed to improve clinical signs due to CPT
3-14 days
Timing needed for Mechanical Ventilation
Time Frame: 3-7 days
Time needed to Mechanical Ventilation support.
3-7 days
Hospitalization time
Time Frame: 5-21 days
All staying duration need for the neonates from admission till discharge from the hospital.
5-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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 (Estimated)

May 10, 2025

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sayed75

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.

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