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【ChiCTR2600118941】Protective Dressing on Reducing Nasal Injury in Preterm Infants treating with CPAP

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基本信息

登记号

ChiCTR2600118941

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-02-13

临床申请受理号

靶点

适应症

Respiratory Distress Syndrome

试验通俗题目

Protective Dressing on Reducing Nasal Injury in Preterm Infants treating with CPAP

试验专业题目

Effect of Protective Dressing on Reducing Nasal Injury in Preterm Infants with Respiratory Distress Syndrome: A Randomized Controlled Trial

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临床试验信息

试验目的

1. Determine the effect of the Protective Dressing on nasal injury for preterm infants with respiratory distress syndrome in the neonatal intensive care unit. 2. Find out the relationship between the effect of Protective Dressing on nasal injury and sociodemographic characteristics of preterm infants with respiratory distress syndrome. 3. Comparing the incidence and severity of nasal injuries between children receiving protective bandages and those receiving routine care.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Participants in this study will be randomly assigned in a 1:1 ratio using a computer-generated randomization sequence.

盲法

This study is open-label; however, the outcome assessor who evaluates nasal injuries will be blinded to group assignment to reduce assessment bias.

试验项目经费来源

Self-funded / No external funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-11-25

试验终止时间

2026-06-30

是否属于一致性

入选标准

1. Preterm infants less than 37 weeks of gestation. 2. Preterm infants who are diagnosed with respiratory distress syndrome (RDS). 3. Preterm infants who are admitted to the neonatal intensive care unit (NICU). 4. Preterm infants who require non-invasive respiratory support via nasal continuous positive airway pressure (CPAP).；

排除标准

1. Full-term infants (gestational age ≥ 37 weeks). 2. Infants with congenital facial or nasal malformations (e.g., cleft lip/palate, nasal hypoplasia). 3. Infants with nasal injury present at birth or before CPAP initiation. 4. Parents or legal guardians who declined to give informed consent. 5. Dead infants；

研究者信息

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试验机构

University of Baghdad/College of Nursing/Pediatric Nursing

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