Status:
RECRUITING
An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse
Lead Sponsor:
University of Liverpool
Conditions:
Preterm
Surgery
Eligibility:
All Genders
22-44 years
Phase:
NA
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 (p...
Detailed Description
Title: Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE) in neonates Population: Preterm infants \<30 weeks gestation requiring a laparotomy/major bowel surgery or diagnosed w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05306925
Start Date
April 14 2022
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (2)
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1
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom, L14 5AB
2
Liverpool Women's Hospital
Liverpool, Merseyside, United Kingdom, L8 7SS