An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal surgery.
研究概览
简要总结
The SuNDiAL study will measure levels of two naturally occurring amino acids: Arginine and Asymmetric Dimethylarginine (ADMA) in neonates undergoing abdominal surgery in the first 5 days of life due to congenital abdominal malformations as the participants recover from surgery.
The investigators hypothesise that the relationship between Arginine and ADMA may be useful in predicting recovery and complications in babies who have had abdominal surgery due to previous research published in adult patients undergoing abdominal surgery. If this relationship is found to be useful there may be options for developing treatments (such as arginine supplementation) in the future to improve recovery and reduce complications in neonates undergoing abdominal surgery.
Neonates born after 35 weeks gestation who have a congenital abdominal malformation who require abdominal surgery in the first 5 days will be eligible to participate in the SuNDiAL study.
Arginine and ADMA will be measured from blood samples that are left over from the participant's blood tests that are taken as part of their routine clinical care. The investigators will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until the participant fully recovers from surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken.
Serums samples that are left over from the babies routine clinical blood tests will be stored securely in the hospitals laboratory until analysis for Arginine and ADMA.
The levels of Arginine and ADMA will be compared to the time it takes the participants to recover from surgery and any complications that may arise following surgery. During the study the study team will use the participants electronic medical record to establish when the participant became fully established on oral feeding and monitor for any complications that occurred during their recovery.
详细描述
The study is a prospective observational, physiological study running across the two trust that form the Liverpool Neonatal Partnership; Liverpool Women's Hospital NHS Foundation Trust and Alder Hey Children's Hospital Foundation Trust.
There is no study intervention and therefore all participants will be managed in accordance with existing local protocols and current accepted clinical practice. Participants will receive standard neonatal and surgical care as per the local clinical guidelines. The participant will have routine blood tests taken as part of their routine care. No additional blood or blood tests will be taken for the SuNDiAL study.
The study will involve the analysis of any blood left over from samples taken routinely pre and postoperatively in infants who have undergone abdominal surgery. Residual serum samples will be analysed from the blood samples taken for routine blood monitoring in the infants enrolled in the study. Biochemical samples will undergo Enzyme-linked immunosorbent assay (ELISA) analysis for ADMA and arginine.
The study period is from preoperatively until 30 days post operatively or until the baby fully recovers from surgery, marked by being fully fed with milk into their stomach. The aim is to obtain at least 1 measurement preoperatively, and a minimum of 4 measurements in the post-operative period. The expectation is that 3-5 measurements first 10 postoperative days should be achievable.
The SuNDiAL study will aim to determine if the level of ADMA and/or Arginine and/or the Arginine to ADMA ratio is associated with the time taken to recover following major abdominal surgery in neonates born after 35 weeks gestation. Recovery will be measured as the time taken to no longer require intravenous nutrition following surgery as the primary objective.
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
- — 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born >35 weeks gestation
- •Have a condition requiring major gastrointestinal surgery
- •Surgery within the first 5 days (120 hours) following birth (including congenital diaphragmatic hernia who are stable enough for surgery in this time frame).
- •Parent(s)/guardian(s) must have a comprehensive understanding of written and spoken English, sufficient to provide informed using the translation services available to the research team.
- •Must be willing and able to provide informed consent in order to take part in the study
排除标准
- •Infants who are unlikely to survive because of poor immediate postoperative condition.
- •Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction.
- •Parent(s)/guardian(s) who are unable to give informed consent.
- •Infants who it is not possible to obtain the minimum required residual serum samples from routine biochemical blood testing as outlined in the study schedule
结局指标
主要结局
The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal surgery.
时间窗: From Enrolment to 30 days following surgery
The primary outcome measure will investigate the level of plasma ADMA, arginine and ARG/ADMA ratio preoperatively and in the immediate postoperative period (5 days) in infants stratified according to typical (\<21 days) or prolonged (\>21 days) postoperative PN dependency. The following measures will be compared between the typical and prolonged recover groups: 1. The pre-operative level (peak/trough as appropriate) of Arginine, ADMA and the ARG/ADMA ratio. 2. The post-operative level (peak/trough as appropriate) within 5 days of surgery of arginine, ADMA and the ARG/ADMA ratio and its relationship to postoperative PN days. 3. The maximum per-infant difference between pre-operative and post-operative levels as defined in a) and b).
次要结局
- Develop a mathematical model to describe the entire postoperative (30 days) trajectory of Arginine, ADMA and the ARG/ADMA ratio in relation to PN dependency.(From enrolment until day 30 post operatively.)
- To study the relationship over time between nutritional intake and arginine, ADMA and the ARG/ADMA ratio.(From enrolment until day 30 postoperatively.)
- The relationship over time between clinically monitored postoperative inflammatory and biochemical markers and arginine, ADMA and the ARG/ADMA ratio(From Enrolment to 30 days post operatively)
- Impact of individual episodes (including duration) of any recognised postoperative complication (eg wound complications, bowel complications, sepsis) on the recovery time and the mathematical model described above.(From enrolment to 30 days post operation)
- Weight Gain/head growth over the study period in relationship to Arginine, ADMA and Arginine to ADMA ratio.(Enrolment to 30 days post operation.)
- Level of care and major treatments (eg ventilation, inotropic support, antibiotics for sepsis) during the study period in relation to Arginine, ADMA and the Arginine to ADMA ratio.(From enrolment to 30 days postoperatively.)