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临床试验/NCT01396642
NCT01396642已完成不适用

Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial

Aga Khan University2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
2
主要终点
Hospital Acquired Blood Stream Infection

研究概览

简要总结

Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of these deaths are attributable to prematurity and infection. With the increasing rate of premature births in some settings, the mortality rate of over 50% among preterm babies in some of the developing countries require inexpensive hospital-based strategies to prevent fatal infections in newborns of these countries. As most of the deaths in preterm neonates are attributable to their vulnerability of infection, a potential low cost intervention like topical emollient therapy can be effectively directed to reduce infection related mortality and morbidity in the developing countries. Topical emollient therapy reduces the rate of infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss consequently conserving heat and energy to promote growth.

The broad goal of the study is to improve the survival rate of hospitalized preterm neonates in the developing countries by decreasing the incidence of infection using low-cost interventions.

HYPOTHESIS:

It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day of life in hospitalized preterm neonates reduces the incidence proportion of hospital acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it is hypothesized that the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18 more as compared to the weight gain in the routine skin care group.

详细描述

Research question:

  1. The primary research question to be addressed via this study is whether the prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, effective in reducing the incidence proportion of hospital acquired infection among preterm neonates by 40% as compared to the routine skin care.
  2. The secondary research question is whether the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day more as compared to the weight gain in the routine skin care group.

Objectives: This study has the following primary objectives:

  1. To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates.

The secondary objective is: 2. To compare the weight gain among the two groups of neonates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Minutes 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Any preterm neonates (>26 weeks and < 37 weeks of gestation by maternal dates)
  • Birth weight of at least 750 gm
  • Age ≤72 hours of life
  • Baseline blood cultures obtained
  • Expected survival > 48 hours (based on the clinical judgment by the physicians)

排除标准

  • Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
  • Neonate within first 24 hours of critical care
  • Life threatening congenital anomalies
  • Congenital skin anomalies
  • Hydrops Fetalis
  • Congenital infection of the skin
  • History of any previous treatment with the ointment
  • Newborns admitted for major surgical procedure with expected high rates of infectious complications.
  • Newborns with positive baseline blood cultures

结局指标

主要结局

Hospital Acquired Blood Stream Infection

时间窗: 28 days of life

Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission.

次要结局

  • Weight Gain(28th Day of Life)

研究者

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

Dr Zulfiqar Ahmed Bhutta

Principal Investigator

Aga Khan University

研究点 (2)

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