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临床试验/NCT03198819
NCT03198819Unknown不适用

Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Surgical site infections

研究概览

简要总结

The correct timing and technique of neural tube defect (NTD) repairs significantly decreases the morbidity and mortality of NTD cases. However, infections related to the surgery are still common. We investigated the effects of topical rifampicin (RIF) combined with routine prophylaxis in newborns with open NTD.

详细描述

The study will be conducted in the Yuzuncu Yil University neonatal intensive care unit, Van, Turkey. The data of 60 neonates diagnosed with open NTD, who will be underwent surgical intervention between August 2016 and December 2017, will be prospectively evaluated. These cases will be randomised.These neonates are going to divide into two groups: the experimental group and the control group. The experimental group will be consisted of 30 newborns diagnosed with open NTDs, administered topical RIF (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open NTDs, administered cefotaxime (50 mg/kg/day, two doses).

In this study, researchers will be investigated whether prophylactic topical RIF applied on a pre-operative mesh in newborns with open NTD reduce the rate of SSIs and meningitis/ VP shunt infections after surgery. For deep incisional primary SSIs will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC) (1). The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. the diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration (2).

Topical RIF Application Procedure The NTD site will be covered with a sterile gauze dressing in the first hours of life after birth in all babies with open NTDs. Then, 10 mg/kg/day RIF will be added to 24 ml of saline (0,9% NaCl), and this will be applied to the mesh as an infusion at a 1cc/h speed . Every day, the same dose of RIF will be delivered to the mesh,changed daily, as a 24-hour infusion until the patient could be operated. After the patient is operated, the RIF infusion delivered to the mesh will be stopped. The cefotaxime treatment will be continued until 72 hours post-op (3).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Newborns who have open NTDs

排除标准

  • •Healthy newborns

研究组 & 干预措施

Rifampisin group

Researchers will administer topical Rifampicin and intravenous cefotaxime

  1. For Rifampicin; 10 mg/kg/day, 24 h infusion on defect area during 3 days
  2. For cefotaxime; 50 mg/kg/day, twice a day, intravenous during 5 days.

干预措施: Local Rifampisin and İnrtravenous cefotaxime (Drug)

Control group

Researchers will only administer intravenous cefotaxime

  1. Doses; 50 mg/kg/day, twice a day, intravenous during 5 days.

干预措施: Local Rifampisin and İnrtravenous cefotaxime (Drug)

结局指标

主要结局

Surgical site infections

时间窗: within 30 days

Deep incisional primary surgical site infections (SSIs) will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC). Accordingly, a diagnosis of infection will be established when fasciae, muscles or deep soft tissues associated with a surgical incision are affected within the first 30 postoperative days or when a foreign body (implant, etc.) leaves at the operation site will be observed within one year after the operation.

The diagnosis of ventriculoperitoneal (VP) shunt infection

时间窗: within one month

The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. The diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration. Shunt infection will be defined as follows: 1. the identification of organisms on a culture or Gram stain from cerebrospinal fluid (CSF), a wound swab or pseudocyst fluid; 2. wound breakdown with visible shunt hardware; 3. the presence of an abdominal pseudocyst (even in the absence of positive cultures); or 4. positive blood cultures in a baby with a VP shunt.

次要结局

  • Length of hospitalization(within 6 months)

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

nihat demir

M.D

Yuzuncu Yıl University

研究点 (1)

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