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临床试验/NCT05077787
NCT05077787已完成不适用

Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

Asir John Samuel2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Total Serum Bilirubin (TSB)

研究概览

简要总结

Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.

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

入排标准

年龄范围
24 Hours 至 10 Days(Child)
性别
All
接受健康志愿者

入选标准

  • New born in Neonatal Intensive Care Unit
  • Stable vitals
  • Full Term and Preterm neonates
  • Gestational age 34 weeks to 40 weeks
  • Birth weight -1800 - 3000 g
  • APGAR Score at birth of 8 -10
  • Total serum bilirubin levels > 10 mg/dL

排除标准

  • 未提供

结局指标

主要结局

Total Serum Bilirubin (TSB)

时间窗: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention

It will measure total bilirubin level in blood of neonates

Transcutaneous Bilirubin (TcB)

时间窗: Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention

Transcutaneous Bilirubin will measure neonatal jaundice.

Weight Gain

时间窗: Changes in the weight will be measured at baseline and at the end of three days intervention

Weight gain will evaluate the change in neonatal weight

次要结局

未报告次要终点

研究者

发起方
Asir John Samuel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asir John Samuel

Associate Professor

Maharishi Markendeswar University (Deemed to be University)

研究点 (2)

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