An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 10 months
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Kingdom
Alder Hey Children's Hospital
RECRUITING
Liverpool
Liverpool Women's Hospital
RECRUITING
Liverpool
Contact Information
Primary
Colin Morgan
colin.morgan@lwh.nhs.uk
+441517089988
Backup
Frances Callaghan
frances.callaghan@nhs.net
+441517089988
Time Frame
Start Date: 2022-04-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 48
Treatments
No_intervention: Standard parenteral nutrition
These infants will form the control group and will receive standard parenteral nutrition. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
Experimental: Arginine supplementation (combined)
These infants will form an intervention group and will receive parenteral nutrition with additional arginine (up to 18% of amino acid make-up) for up to 14 days post-op and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
Experimental: Arginine supplementation (oral only)
These infants will form an intervention group and will receive standard parenteral nutrition and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
Sponsors
Leads: University of Liverpool

This content was sourced from clinicaltrials.gov