The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intervention time
研究概览
简要总结
Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%.
Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in expediting diagnosis and management of NEC.
Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks.
Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominal distension
- •Visible bowels loops
- •Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of >50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis)
- •Temperature instability (defined as ≥ 2 consecutive measurements)
- •Frank bloody stools
- •Cardiovascular instability (hypotension; defined as MAP < 30mmHg, tachycardia >160/' or bradycardia < 80/')
- •Recurrent apnea
- •Increase of abdominal girth > 2cm (allowing inter-observer variability of 1 cm) within 12 h
- •Abdominal wall erythemia
- •And/or at least 2 of the below laboratory findings5:
- •Thrombocytopenia < 50 x103/uL
- •Leukopenia <6 x106/uL
- •CRP > 10 mg/L
- •PCT > 1 ng/ml
- •Coagulopathy
排除标准
- •• < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound)
- •Congenital abnormalities
- •No parental consent
结局指标
主要结局
Intervention time
时间窗: until 40 weeks of post-conceptional age
The time required to initiate conservative and/or surgical treatment after diagnosing NEC with AR versus AR and AUS
次要结局
- Sensitivity and specificity(until 40 weeks of post-conceptual age)
研究者
Renata Bokiniec
Renata Bokiniec MD PhD
Princess Anna Mazowiecka Hospital, Warsaw, Poland