Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Mortality in preterm newborns with necrotizing enterocolitis
研究概览
简要总结
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis. The main questions it aims to answer are:
- are the combination of metabolic derangement components and paracentesis good indicators for determining early surgery in preterm patients with necrotizing enterocolitis?
- With the use of the previously mentioned indicators, can mortality in these patients be reduced? Participants will undergo determination of the 7 parameters of the metabolic deterioration components and those with three or more positive points will undergo paracentesis and if this is also positive, it will be determined that the patient requires surgical management.
The researchers will compare with a control group to see the differences in surgical variables (length of necrotic bowel, length of viable bowel, need for intestinal diversion and surgical reintervention) and mortality.
详细描述
Controlled, randomized, double-blind clinical trial approved by the hospital's Ethics and Research Committee, subject to the Declaration of Helsinki. This study follows the CONSORT trial reporting guidelines. Patients younger than 37 weeks of gestation, with NEC stage IIa or greater according to Bell criteria were included.
Two groups of patients were formed (Control and Intervention), randomization was based on a randomization sequence generated using the Graphard 2021 program.
Control group: determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours.
Intervention Group: CMD measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made.
Both groups received the same pre- and post-surgical medical management by neonatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The diagnosis, application of randomization to each group and blood sampling were performed by the neonatology staff, both the patients and the surgical team that provided care were blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients equal to or less than 36.6 weeks gestation, with a diagnosis of NEC stage II A or greater according to Bell criteria.
排除标准
- •Patients with a history of gastroschisis, suspected Hirschsprung's disease. Patients who do not give authorization for participation.
- •Elimination criteria:
- •Patients who during follow-up died due to some other condition. Patients who during the study declined to participate. Patients who in the surgical findings had data of Spontaneous Intestinal Perforation.
结局指标
主要结局
Mortality in preterm newborns with necrotizing enterocolitis
时间窗: Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.
The mortality of patients with necrotizing enterocolitis who required surgical management in both groups was determined.
次要结局
未报告次要终点
研究者
Gerardo Fernández Ortega
Pediatric Surgery Specialty Coordinator / Principal Investigator
Hospital General de Mexico