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An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

RecruitingNAAges 22 Weeks - 44 WeeksAllUniversity of Liverpool
NCT05306925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 receiv

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📋 Eligibility rules (as published)
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
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What it tests

  • Arginine
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Where

2 sites
Alder Hey Children's Hospital
Liverpool, United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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