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临床试验/NCT04760509
NCT04760509Unknown不适用

Short- Term Follow up Of Neonates Born With Neural Tube Defect

Hacettepe University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
the day of surgery to be performed in the postnatal period

研究概览

简要总结

Neural tube defects (NTD), which is the most common anomaly of the central nervous system, which can be diagnosed during antenatal period, brings many problems both in the neonatal period and in advanced ages. Open neural tube defects, in particular, progress with sensory-motor deficits due to the risk of infection and neural tissue loss from birth, and should be followed closely from the neonatal period. Newborns born with a neural tube defect should be operated within the first 72 hours postnatal and the defect should be closed.

In this hospital, newborns with NTD are monitored in our neonatal surgery intensive care unit before and after surgery. Neonatal specialists, neurosurgeons and other specialists when there is an additional anomaly evaluate the baby as multidisciplinary.

In this project, the short-term follow-up data of babies with NTD who have been followed up in this neonatal surgery intensive care unit for the last fifteen years will be evaluated retrospectively.

详细描述

Neural tube defects (NTD), which is the most common anomaly of the central nervous system, which can be diagnosed during antenatal period, brings many problems both in the neonatal period and in advanced ages. Open neural tube defects, in particular, progress with sensory-motor deficits due to the risk of infection and neural tissue loss from birth, and should be followed closely from the neonatal period. Newborns born with a neural tube defect should be operated within the first 72 hours postnatal and the defect should be closed.

In this hospital, newborns with NTD are monitored in neonatal surgery intensive care unit before and after surgery. Neonatal specialists, neurosurgeons and other specialists when there is an additional anomaly evaluate the baby as multidisciplinary.

In this project, the short-term follow-up data of babies with NTD who have been followed up in neonatal surgery intensive care unit for the last fifteen years will be evaluated retrospectively.Information of patients hospitalized with a diagnosis of neural tube defect in the neonatal intensive care unit between January 1, 2006 and January 1, 2021 will be recorded in the file. In addition to demographic information such as antenatal follow-up data of patients, maternal diseases, birth weights, birth weeks, delivery types, neurological examinations, laboratory findings, imaging (such as graphy, tomography, ultrasonography), surgery notes, additional anomalies from the hospital system retrospectively will be saved. Immediately after babies with NTD are born, the defect should be protected in the delivery room with a wet sterile sponge and the baby should be placed in a lateral or prone position. Since the risk of meningitis is high and the destruction of the neural tissue within the pouch will increase within days, the sac repair should be performed within the first 72 hours. Antibiotics should be initiated empirically in these patients with high risk of meningitis. In the postoperative follow-up; The patient should be monitored in terms of wound infection of the repaired sac, bosom leakage, fistula formation and hydrocephalus.

In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively. As a result of this data evaluation to be made over the hospital information system, "Hacettepe University Neonatal Intensive Care Unit patient follow-up with NTD" will contribute to the literature.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Babies who have been hospitalized in the Neonatal Intensive Care Unit of Hacettepe University İhsan Dogramaci Children's Hospital and who have been operated due to neural tube defects will be taken.

排除标准

  • Patients whose file records cannot be reached will not be included.

结局指标

主要结局

the day of surgery to be performed in the postnatal period

时间窗: 8 months

It is aimed to demonstrate the effects of early or late surgery day on the baby in the postnatal period.

次要结局

未报告次要终点

研究者

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

Umit Ayse Tandircioglu

Medical Doctor

Hacettepe University

研究点 (1)

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