Actively Recruiting

Phase Not Applicable
Age: 22Weeks - 44Weeks
All Genders
NCT05306925

An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

Led by University of Liverpool · Updated on 2026-02-18

48

Participants Needed

2

Research Sites

246 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

Who Can Participate

Age: 22Weeks - 44Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born less than 30 weeks gestation requiring laparotomy or major bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge
  • Term and near term infants born over 35 weeks gestation requiring laparotomy or major bowel surgery in the first 3 days of life (gastroschisis or major bowel atresias expected to require at least 7 days of parenteral nutrition)
Not Eligible

You will not qualify if you...

  • Infants unlikely to survive due to poor immediate postoperative condition
  • Infants with known or suspected inborn error of metabolism or serious liver dysfunction
  • Parents unable to give informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Alder Hey Children's Hospital

Liverpool, Merseyside, United Kingdom, L14 5AB

Actively Recruiting

2

Liverpool Women's Hospital

Liverpool, Merseyside, United Kingdom, L8 7SS

Actively Recruiting

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Research Team

C

Colin Morgan

CONTACT

F

Frances Callaghan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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