Actively Recruiting
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
Led by Liverpool Women's NHS Foundation Trust · Updated on 2025-09-29
30
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
Sponsors
L
Liverpool Women's NHS Foundation Trust
Lead Sponsor
A
Alder Hey Children's NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born more than 35 weeks gestation
- Have a condition requiring major gastrointestinal surgery
- Surgery within the first 5 days (120 hours) following birth, including stable congenital diaphragmatic hernia cases
- Parent(s)/guardian(s) must understand written and spoken English sufficiently to provide informed consent
- Must be willing and able to provide informed consent
You will not qualify if you...
- Infants unlikely to survive due to poor immediate postoperative condition
- Infants known or suspected to have inborn errors of metabolism or serious liver dysfunction
- Parent(s)/guardian(s) unable to give informed consent
- Infants from whom the minimum required residual serum samples cannot be obtained from routine blood tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Alder Hey Childrens Hospital NSH Foundation Trust
Liverpool, Merseyside, United Kingdom, L12 2AP
Actively Recruiting
2
Liverpool Womens Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L8 7SS
Actively Recruiting
Research Team
C
Colin Morgan
CONTACT
J
Joshua Stead
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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