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临床试验/CTRI/2025/11/097459
CTRI/2025/11/097459尚未招募不适用

Effectiveness of aluminum foil-assisted phototherapy on bilirubin levels and body temperature among neonates in the selected Tertiary care hospital Mangalore

Ankitha V1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in total serum bilirubin levels among term neonates receiving aluminum foil-assisted phototherapy compared to standard phototherapy.

研究概览

简要总结

This study aims to evaluate the effectiveness of aluminum foil-assisted phototherapy in reducing serum bilirubin levels and hyperthermia in neonates with jaundice admitted to the Neonatal Intensive Care Unit (NICU) at a selected tertiary hospital affiliated with a university in Mangalore, India. A quasi-experimental study design will be employed. Neonates requiring phototherapy will be assigned to the control and experimental groups. Purposive sampling will select neonates meeting the inclusion criteria (e.g., diagnosed with neonatal jaundice requiring phototherapy). Exclusion criteria will include contraindications to phototherapy (e.g., severe hemolytic disease, suspected sepsis). In the intervention group, phototherapy will be administered with strategically placed aluminum foil-covered, bow-shaped acrylic sheets molded and positioned above the infant’s cradle to enhance heat retention and potentially improve therapeutic efficacy. The control group will receive standard phototherapy. This study has the potential to provide valuable evidence on the effectiveness and safety of aluminum foil-assisted phototherapy in managing neonatal jaundice. Findings from this study may inform clinical practice guidelines and improve the care of neonates with jaundice.

研究设计

研究类型
Interventional

入排标准

年龄范围
1.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • Term nenoates who had 1.Pathological jaundice 2.the bilirubin level greater than or equal to twelve milligrams per deciliter 3.full-term neonates diagnosed within the first seven days of life 4.recommended double surface phototherapy for first time.

排除标准

  • Term neonates who had 1.hyperbilirubinemia with major congenital anomalies, hemodynamically unstable neonates and neonates on ventilator.
  • 2.recommended to undergo exchanges transfusion.

结局指标

主要结局

Change in total serum bilirubin levels among term neonates receiving aluminum foil-assisted phototherapy compared to standard phototherapy.

时间窗: At baseline (before initiation of phototherapy), at 24 hours, and at 48 hours after initiation of phototherapy.

次要结局

  • Change in body temperature of neonates during phototherapy sessions.(At baseline and at six hourly intervals during phototherapy.)

研究者

发起方
Ankitha V
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ankitha V

Yenepoya nursing college

研究点 (1)

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