Actively Recruiting
An Exploratory Study of Arginine Supplementation and the Postoperative Immune Response in Neonates
Led by University of Liverpool · Updated on 2026-02-18
48
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of arginine supplementation on immune function in infants who have undergone major bowel surgery or have necrotising enterocolitis. This exploratory study will compare gene expression related to immune response in preterm and term infants receiving different nutrition regimens. The goal is to understand how arginine affects genes involved in nutrition and infection in postoperative babies. The study involves 48 infants divided into three groups: one receiving standard parenteral nutrition without added arginine, one receiving parenteral nutrition with added arginine plus oral arginine supplementation, and one receiving standard parenteral nutrition with oral arginine supplementation only. Arginine dosing will begin with the first enteral feeds and adjust based on feeding progress. Treatment lasts up to 30 days post-surgery or diagnosis. Participants will have blood samples collected at specified intervals up to 30 days after surgery to analyze gene expression, amino acid levels, ammonia, and metabolomics. Routine nutritional intake and clinical lab data will also be recorded. Researchers will assess changes in immune-related gene activity, metabolomic profiles, and growth during the study period. The study is conducted across two neonatal centers under a neonatal partnership.
CONDITIONS
Brief Title
An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born less than 30 weeks gestation requiring major bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge
- Term and near term infants born more than 35 weeks gestation requiring major bowel surgery in the first 3 days of life
- Infants expected to require at least 7 days of parenteral nutrition
- Parents able to give informed consent
You will not qualify if you...
- Infants unlikely to survive due to poor immediate postoperative condition
- Infants with known or suspected inborn error of metabolism or serious liver dysfunction
- Parents unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 5 days after surgery or diagnosis
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 30 days post-operatively
Participants receive either standard parenteral nutrition or parenteral nutrition combined with enteral arginine supplementation for up to 14 days post-operatively, followed by enteral arginine supplementation alone up to 30 days post-operatively.
Visits on days 3, 10, and 30 post-surgery for blood sampling and assessments
Trial Site Locations
Total: 2 locations
1
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom, L14 5AB
Actively Recruiting
2
Liverpool Women's Hospital
Liverpool, Merseyside, United Kingdom, L8 7SS
Actively Recruiting
Research Team
C
Colin Morgan
F
Frances Callaghan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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