An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

Launched by UNIVERSITY OF LIVERPOOL · Mar 23, 2022

Keywords

ClinConnect Summary

The ASPIRE trial is a study looking at how arginine, an important nutrient, may help improve the immune system in infants who have had major bowel surgery or have a serious condition called necrotising enterocolitis (NEC). Researchers will compare different ways of giving arginine to 48 infants, including both preterm and term babies. Some will receive arginine through a tube (intravenous feeding) and by mouth, while others will get it only by mouth, or not at all. The goal is to see how these different approaches affect their immune system and overall recovery after surgery.

To be eligible for the study, infants must be either very premature (born before 30 weeks) or term/near term (born after 35 weeks) and require major surgery shortly after birth. Unfortunately, infants who are not likely to survive surgery or have certain serious health conditions cannot participate. During the study, doctors will monitor what the babies eat and perform routine tests on their blood over the first 30 days after surgery to see how their bodies respond to the different types of feeding. This research could help improve recovery and health outcomes for these vulnerable infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preterm infants born \<30 weeks gestation requiring laparotomy/major bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge
• • Term and near term infants (born\>35 weeks gestation) requiring laparotomy/major bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days of PN)
• Exclusion Criteria:
• • 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
• • Parents who are unable to give informed consent