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临床试验/CTRI/2022/12/048207
CTRI/2022/12/048207已完成不适用

Role of Massage with Virgin Coconut Oil-based Emollient on Growth, Bone Strength and Neurodevelopment of Newborns

Marico Limited1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2022年12月25日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
342
试验地点
1
主要终点
Weight gain/day

研究概览

简要总结

Coconut oil supplementation is helpful in maturity of skin with additional anti-microbial effect. This study will be conducted to determine the efficacy of coconut oil massage in newborn on their growth, bone strength, neurodevelopment and brain growth**.**Newborn discharged from maternity ward or Sick Newborn Care Unit and aged ≤15 days will be included in this study. Exclusion criteria were major systemic illness, refusal of consent, and planning to change residence. Infants of group A will receive massage with coconut oil-based emollient as described by Kumar et al for three months. Newborns of group B receive only massage without any emollient application. Anthropometric parameters of all newborns will be measured fortnightly till 6 month. Skin condition of the newborn will be assessed at the time of recruitment,14th and 28th day. Sound velocity at the upper end of tibia will be measured at 3rd and 6th month (±7 days) by trained radiologist. Neurodevelopment will be assessed at 6th month by DASII scale. Collected data will be entered in Microsoft excel worksheet after double-checking. SPSS version 19.0 will be used for data-analysis. P<0.05 will be taken as statistically significant. Coconut oil massage might be helpful in reducing the neonatal and infant mortality in an economic way.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 15.00 Day(s)(—)
性别
All

入选标准

  • Parents/ legal guardians of all newborn discharged at an age of ≤15 days will be approached for inclusion in the study.

排除标准

  • Major systemic illness Refusal of consent Planning to change residence.

结局指标

主要结局

Weight gain/day

时间窗: day 30

次要结局

  • Complications(Upto 6th month)
  • Velocity of sound at upper end of tibia(3rd and 6th month)
  • Anthropometric parameters(Upto 6 months)
  • Neonatal skin condition score(Upto 30 days)
  • Neurodevelopment(6th month)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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