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

NCT ID: NCT06950723

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2025-07-15

Brief Summary

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.

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.

Conditions

Hypoxic Ischemic Encephalopathy of Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chest physical Therapy group

Study group

Group Type: EXPERIMENTAL

Chest Physical Therapy (CPT) modalities , Medical Treatment

Intervention Type: OTHER

Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.

Medical treatment group

Control group

Group Type: EXPERIMENTAL

Chest Physical Therapy (CPT) modalities , Medical Treatment

Intervention Type: OTHER

Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.

Interventions

Chest Physical Therapy (CPT) modalities , Medical Treatment

Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Elsayed Mehrem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elsayed Mehrem, Associate Professor

Role: CONTACT

sayed7555@yahoo.com

+201006973334

Other Identifiers

Sayed75

Identifier Type: -

Identifier Source: org_study_id