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临床试验/NCT06950723
NCT06950723尚未招募不适用

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

Cairo University0 个研究点目标入组 50 人开始时间: 2025年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Timing of Arterial blood gases improvement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 10 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates with chest problems post Hypoxic-ischemic encephalopathy

排除标准

  • •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.

研究组 & 干预措施

Chest physical Therapy group

Experimental

Study group

干预措施: Chest Physical Therapy (CPT) modalities , Medical Treatment (Other)

Medical treatment group

Experimental

Control group

干预措施: Chest Physical Therapy (CPT) modalities , Medical Treatment (Other)

结局指标

主要结局

Timing of Arterial blood gases improvement

时间窗: 3-14 days

Time needed to improve Arterial blood gases due to CPT

Timing required for clinical improvement

时间窗: 3-14 days

Time needed to improve clinical signs due to CPT

Timing needed for Mechanical Ventilation

时间窗: 3-7 days

Time needed to Mechanical Ventilation support.

Hospitalization time

时间窗: 5-21 days

All staying duration need for the neonates from admission till discharge from the hospital.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elsayed Mehrem

Principal Investigator

Cairo University

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