The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation Among Neonates With Hypoxic-ischemic Encephalopathy Under Therapeutic Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cerebral and mesenteric blood flow velocities and oxygenation
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:
1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.
详细描述
Objectives: The investigators aimed to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with HIE.
Methods: This prospective, randomized controlled study was conducted between September 2020 to August 2022. The infants receiving MEN during hypothermia (n =30) and those who were not fed (n=30) constituted the study and control groups. Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and after feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial.
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by
- •a pH of ≤ 7.0 and/or
- •base deficit >-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat & Sarnat classification based on neurological examination were treated with TH.
排除标准
- •Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.
结局指标
主要结局
Cerebral and mesenteric blood flow velocities and oxygenation
时间窗: (From postnatal first day until postnatal 4 th day)Doppler US of SMA and MCA performed before feeding (15-30 minutes before) and 60 minutes after feeding
Cerebral and mesenteric blood flow velocities with Doppler US
Cerebral and mesenteric rSO2 values
时间窗: (From postnatal first day until postnatal 4 th day) Recording of NIRS data was commenced 60minutes before the initiation of TH and was continued during the procedure till 24 hours after cessation of TH
Cerebral and mesenteric rSO2 values with NIRS
次要结局
- Development of NEC(From admission to NICU till postnatal 15th day or hospital discharge whichever came first,)
- Feeding intolerance(From admission to NICU till postnatal 15th day or hospital discharge whichever came first,)
- Time to full enteral feeding(From admission to NICU till postnatal 15th day or hospital discharge whichever came first,)
研究者
DİDEM ARMAN
Associate Professor
Istanbul Training and Research Hospital