NCT05306925 An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse
| NCT ID | NCT05306925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Liverpool |
| Condition | Preterm |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2022-04-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05306925 clinical trial?
This trial is open to participants of all sexes, aged 22 Weeks or older, up to 44 Weeks, studying Preterm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05306925 currently recruiting?
Yes, NCT05306925 is actively recruiting participants. Contact the research team at colin.morgan@lwh.nhs.uk for enrollment information.
Where is the NCT05306925 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom, Liverpool, United Kingdom.
Who is sponsoring the NCT05306925 clinical trial?
NCT05306925 is sponsored by University of Liverpool. The trial plans to enroll 48 participants.