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临床试验/NCT01498133
NCT01498133Unknown2 期

Does Skin-to-skin Contact Promote Bacterial Decolonization in Preterm Infants in Neonatal Intensive Care Unit? A Randomized, Single-blinded Controlled Trial

Universidade Federal do Maranhão2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
102
试验地点
2
主要终点
Decolonization of newborns' nostrils

研究概览

简要总结

BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care Unit), but can trigger bacterial resistance. The objective of this study was to determine whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin Resistant Staphylococcus Aureus) with their mothers could be an effective alternative for biological control of bacterial colonization.

METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals in São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay >4 days, newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacteria. Randomization was performed using a computer generated random numbers algorithm. Allocation to intervention and control groups was performed for each eligible newborn using a sealed opaque envelope. In the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. The control group (n = 49) received routine care without skin-to-skin contact. There was no masking of newborn's mothers or researchers, but the individuals who carried out bacterial cultures and assessed results were kept blind to group allocation.

The primary outcome was decolonization of newborns' nostrils after 7 days of intervention. Safety was assessed by monitoring vital signs of newborns during the intervention. The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.

FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • singleton neonates,
  • born in the three institutions of the study
  • birth weight from 1300 to 1800g
  • length of stay >=4 days,
  • newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacterias.

排除标准

  • infants below 1300g and over 1800g,

结局指标

主要结局

Decolonization of newborns' nostrils

时间窗: 7 days

The primary outcome was decolonization of newborns' nostrils after 7 days of intervention

次要结局

  • late onset presumed sepsis(The end of hospitalization period or 28 days of life, whatever happened first.)

研究者

发起方
Universidade Federal do Maranhão
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Lamy Filho

Principal Investigator

Universidade Federal do Maranhão

研究点 (2)

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