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临床试验/NCT02683915
NCT02683915已完成不适用

Acute Kidney Injury in Asphyxiated Infants Treated by Therapeutic Hypothermia

Mansoura University Children Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Acute kidney injury

研究概览

简要总结

This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.

详细描述

The study will be conducted at the NICU of Mansoura University children's Hospital and regional General Hospital where brain cooling is not available.

Infants will be identified in the delivery room or the NICU based on a per-specified inclusion and exclusion criteria. The admitting physician will inform the study team upon admitting the infants to prepare for obtaining consent form.

When a patient is admitted and satisfies the inclusion criteria, one of the investigators or delegate will approach the parent(s). Patient identification will be done by admitting residents or the nurse practitioners. Parents will be approached by the residents or the nurse practitioners while the signature of the consent form in case of agreement will be obtained by one of the investigators who are not responsible about the care of the infant. Using language understandable to the parent(s), the study protocol will be described in detail outlining the procedure and describing any potential risks. All parents will be specifically informed that a decision not to participate in the research study will in no way compromise their child's care. If the parent(s) agree that their child participate in the study, written informed consent will be obtained. A copy of the consent form will be kept with the investigators.

Infants will be classified into two groups, either group 1 (Cooled group) or group 2 (Non-cooled group) who missed opportunity to be identified within proper time.Categorization will be center-based according to the feasibility of cooling devices at proper time (the first 12 hours of the baby's life).

Group 1 (Cooled group) Cooling procedure We will fit a cooling cap (Olympic Medical Cool Care System, Olympic Medical) around the head for 72 h. The system consists of a small thermostatically controlled cooling unit with a pump that circulated water through the cap. The initial water temperature is set between 8°C and 12°C. All infants will be nursed under a radiant overhead heater, which is servo-controlled to the infant's abdominal skin temperature and adjusted to maintain the rectal temperature at 33.5-34.5ºC. Adjustments will be made to the cooling cap water temperature to stay within these limits. At the start of hypothermia, the overhead heater will be turned off for 20-30 min to accelerate cooling, and then turned back on once the rectal temperature had fallen to 35.5ºC.

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
30 Minutes 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Acute kidney injury

时间窗: 15 days

A serum createnine-based modification of the Acute Kidney Injury Network criteria: Stage 0: No change in SCr, Stage 1:↑SCr 0.3 mg/dL or ↑SCr 150- \<200% from previous trough value, Stage 2: ↑ SCr 200- \<300% from previous trough value, Stage 3: ↑ SCr ≥300% from previous trough value, SCr 2.5 mg/dL, or dialysis

次要结局

未报告次要终点

研究者

发起方
Mansoura University Children Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nehad Nasef

Assistant Professor of pediatrics

Mansoura University Children Hospital

研究点 (1)

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