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.
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.
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
The study population with be of 30 infants born \>35 weeks gestation and has a condition requiring major gastrointestinal surgery within 5 days (120 hours) of birth. This is expected to include predominantly congenital gut malformations: gastroschisis, gut atresias, volvulus and congenital diaphragmatic hernia (who are stable enough for surgery in this time frame). Patient will be recruited over a 1 year period. These infants will be born at Liverpool Women's Hospital or at their local hospital in the north west of England region, and transferred to Alder Hey Children's Hospital for their operation, either directly or via Liverpool Women's Hospital Neonatal Intensive Care Unit. They will recover in Alder Hey Children's Hospital's Paediatric Intensive Care Unit or Neonatal Surgical Unit and may later be transferred back to Liverpool Women's Hospital.
Cohort
Prospective
Abdominal Surgery for congenital gut malformation in the first 5 days of life.
Procedure/SurgeryAbdominal Surgery for congenital gut malformation in the first 5 days of life. Procedure will depend on the congenital gut malformation.
The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal 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).
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.
To study the relationship over time between nutritional intake and arginine, ADMA and the ARG/ADMA ratio.
The relationship over time between clinically monitored postoperative inflammatory and biochemical markers and arginine, ADMA and the ARG/ADMA ratio
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.
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Liverpool Women's NHS Foundation Trust
Lead sponsor
Alder Hey Children's NHS Foundation Trust
Collaborator
