An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

Recruiting now · Not applicable

Conditions studied: Preterm, Surgery, Nutritional Deficiency, Immune System and Related Disorders

In brief

ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term/near term infants. 16 of these infants (8 preterm and 8 term/near term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.

Key facts

Study ID

NCT05306925

Run by

University of Liverpool

People needed

48

Starts

2022-04-14

Expected to finish

2026-12-31

Last updated by the study team

2026-02-18

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Alder Hey Children's Hospital — Liverpool, Merseyside, United Kingdom (enrolling)
• Liverpool Women's Hospital — Liverpool, Merseyside, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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