Exploring arginine supplementation for immune response in postoperative infants
Official title: An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE)
Run by University of Liverpool · NCT05306925 · Data updated 2026-11-12
This study is testing if giving arginine supplements can help improve the immune response in infants who have had major bowel surgery or have a serious gut condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Weeks to 44 Weeks |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University of Liverpool Academic / other |
| Locations | 2 sites (Liverpool, Merseyside and 1 other locations) |
| Status | Recruiting |
| Started | April 14, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT05306925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include preterm infants under 30 weeks gestation or term infants over 35 weeks requiring major bowel surgery.
✕Probably not a fit
Patients unlikely to benefit include those with poor immediate postoperative conditions or serious metabolic disorders.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of arginine supplementation on immune function in infants who have undergone major bowel surgery or have been diagnosed with necrotising enterocolitis. A total of 48 infants will be recruited, divided into preterm and term groups, with some receiving arginine in both oral and parenteral forms, while others will receive standard nutrition. The study will assess blood arginine levels and related gene expressions to understand the nutritional impact on immune response. It will take place across two sites, Alder Hey Children's Hospital and Liverpool Women's Hospital, over a period of 24-36 months.
Why it matters
Potential benefit: If successful, this study could enhance postoperative recovery and immune function in vulnerable infants.
How similar studies have gone: While the specific approach of arginine supplementation in this context is novel, similar nutritional interventions have shown promise in enhancing immune responses in other populations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom Recruiting -
Liverpool Women's Hospital
Liverpool, Merseyside, United Kingdom Recruiting
Study contacts
- Study coordinator: Colin Morgan
- Email: colin.morgan@lwh.nhs.uk
- Phone: +441517089988
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.