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临床试验/NCT03533439
NCT03533439已完成不适用

Regional Haemoglobin Oxygen Saturation in the Splanchnic Circulation in Neonates With Gastroschisis; Quantifying and Qualifying the Role for Routine Monitoring

NHS Lothian0 个研究点目标入组 19 人开始时间: 2013年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
19
主要终点
The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2

研究概览

简要总结

Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%. The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo.

Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this does not seem to be the norm, as most cases do well in the silo. Cases of intestinal ischaemia within the silo have been described in patients. Any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome.

Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen saturation using NIRS is already in clinical application in other neonatal and paediatric medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery.

The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients.

The aim of the study will be to:

  1. Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
  2. Identify the clinical progress of patients with gastroschisis in the postnatal period
  3. Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Gastroschisis diagnosed antenatally or at birth

排除标准

  • Associated congenital condition affecting respiratory system , cardiovascular system or global development
  • Generalised sepsis

结局指标

主要结局

The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2

时间窗: Through study completion, an average of 6 weeks

次要结局

  • Changes in renal oxygenation measured by near infra-red spectroscopy(Through study completion, an average of 6 weeks)
  • Time to full feeds(Through study completion, an average of 6 weeks)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

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