SuNDiAL
Research type
Research Study
Full title
An exploratory physiological study of post-operative recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL).
IRAS ID
349681
Contact name
Colin Morgan
Contact email
Sponsor organisation
Liverpool Women’s Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
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 recover from their surgery.
We 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 baby’s blood tests that are taken as part of their routine clinical care. We will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until they fully recover from their surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken.
We will store samples that are left over from the babies routine clinical blood tests 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 babies to recover from surgery and any complications that may arise following surgery. During the study the study team will use the patients electronic medical record to establish when the patient became fully established on oral feeding and monitor for any complications that occurred during their recovery.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0276
Date of REC Opinion
13 Dec 2024
REC opinion
Favourable Opinion