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临床试验/NCT07156721
NCT07156721已完成不适用

The Effect of Using a White Reflective Drape During Phototherapy on Bilirubin Levels and Hospital Stay in Neonates

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Change in serum bilirubin level at 24 hours

研究概览

简要总结

This randomized controlled trial investigated the effect of using a white reflective drape during phototherapy on serum bilirubin levels and hospital stay in neonates diagnosed with hyperbilirubinemia. A total of 102 newborns (≥34 weeks gestational age) were randomized into two groups: an intervention group (phototherapy with a white reflective drape) and a control group (standard phototherapy). Serum bilirubin levels were measured at baseline, 4 hours, and 24 hours. The primary outcome was the reduction in serum bilirubin at 24 hours, and secondary outcomes included bilirubin reduction rates at different time intervals, phototherapy duration, and hospital stay.

详细描述

Neonatal hyperbilirubinemia is one of the most common conditions in the neonatal period and may lead to severe complications if untreated. Phototherapy is the standard treatment; however, its effectiveness can be improved by using reflective materials to enhance light exposure.

In this single-center randomized controlled trial, conducted between October 2023 and August 2024 at the Neonatal Intensive Care Unit of a University Hospital in Ankara, Turkey, a total of 102 neonates with hyperbilirubinemia were enrolled. Inclusion criteria were: gestational age ≥34 weeks, diagnosis of hyperbilirubinemia, physician decision to initiate phototherapy, and written parental consent. Exclusion criteria included critical health conditions (e.g., Extracorporeal membrane oxygenation or nitric oxide therapy), congenital anomalies, blood group incompatibility or positive Coombs test, and bilirubin at exchange transfusion threshold.

Participants were randomized into two groups (n=51 per group). In the intervention group, a white reflective drape made of double-layer alpaca fabric (125 × 105 cm) was placed around the phototherapy device (three sides plus overhead) and a white sheet was placed under the neonate. The control group received standard phototherapy without a reflective drape. Phototherapy was administered using an Ertunç Özcan device with 24 blue LED lamps and one red focusing light. Serum bilirubin levels were measured from capillary blood samples at baseline, 4 hours, and 24 hours, maintaining a device-to-infant distance of 35 cm.

The primary outcome was the change in serum bilirubin at 24 hours. Secondary outcomes included bilirubin reduction rates (0-4h, 4-24h, 0-24h), phototherapy duration, and hospital length of stay. Statistical analysis was performed using SPSS v23, applying t-test, Mann-Whitney U, Friedman, and Dunn's tests, with significance set at p<0.05.

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
None

盲法说明

This was an open-label study; no masking was applied.

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age ≥ 34 weeks
  • Diagnosed with hyperbilirubinemia
  • Physician decision to initiate phototherapy Written informed consent obtained from parents

排除标准

  • Critical illness (e.g., ECMO, nitric oxide therapy)
  • Congenital anomalies
  • Blood group incompatibility or positive Coombs test
  • Bilirubin level at exchange transfusion threshold

结局指标

主要结局

Change in serum bilirubin level at 24 hours

时间窗: 24 hours

Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.

次要结局

  • Duration of phototherapy(Up to 72 hours)
  • Hospital length of stay due to hyperbilirubinemia(Up to 7 days)
  • Bilirubin change rate between 0-4 hours(0-4 hours)
  • Bilirubin change rate between 4-24 hours(4-24 hours)
  • Bilirubin change rate between 0-24 hours(0-24 hours)
  • Change in serum bilirubin level at 4 hours(4 hours)
  • Change in serum bilirubin level at 4 hours(4 hours)
  • Bilirubin change rate between 0-4 hours(0-4 hours)
  • Bilirubin change rate between 4-24 hours(4-24 hours)
  • Bilirubin change rate between 0-24 hours(0-24 hours)
  • Duration of phototherapy(Up to 72 hours)
  • Hospital length of stay due to hyperbilirubinemia(Up to 7 days)

研究者

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

Sıla İpek DURMUŞ

Research Assistant

Saglik Bilimleri Universitesi

研究点 (2)

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