Study of Arginine Supplementation Effects on Immune Response in Newborns After Major Bowel Surgery or Necrotising Enterocolitis

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.

An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse