Neonatal Arginine Supplementation and Postoperative Immune Response
Research type
Research Study
Full title
An exploratory study of Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE) in neonates
IRAS ID
287793
Contact name
Colin Morgan
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Infections are the most frequent cause of morbidity after surgery and half of all hospital-acquired infections occur in high-risk surgical populations. Surgical stress predisposes patients to immune dysfunction, placing them at higher risk of infection. These risks are increased with malnutrition or in other nutritional vulnerable groups such as the newborn, especially if born preterm. Amino acids are used as building blocks for protein synthesis and are important for many biochemical pathways and growth. There is evidence that deficiency of an amino acid named Arginine may impair a newborn infant’s ability to fight infection. Premature infants or infants who have required gut surgery often lack arginine because they are fed via parenteral (intravenous) nutrition (PN) rather than via milk feeds. Our previous exploratory physiological studies explored the effect of current PN and new formulations of PN with added arginine on blood arginine levels and the changes in gene expression over the first two weeks of life in very premature infants. This showed arginine affects genes involved with nutrition and fighting infection. We will undertake a two-centre exploratory physiological study in 32 infants who have required laparotomy/major bowel surgery and require PN. We will study 16 preterm and 16 term infants. Half the infants in each group will receive standard PN and half will receive PN with additional arginine. We will record nutritional intake, growth and body composition measurements as well as routine biochemical testing data (including blood amino acid levels) collected over the first 30 days after surgery. We will take extra blood for analysis on day 3, day 10 and day 30 post-op to look for changes in gene expression, additional metabolic markers and metabolomics (study of very small molecules). These techniques will allow us to examine the effects of arginine on biological systems in post-operative neonates.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
21/EE/0225
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion