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

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: Hypoxic Ischemic Encephalopathy of Newborn
• Intervention / Treatment: Other: Chest Physical Therapy (CPT) modalities , Medical 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

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

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: Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Signs and Symptoms, Respiratory; Hypoxia, Brain; Ischemia; Hypoxia; Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain
• 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