Preterm Arginine INTake study
Research type
Research Study
Full title
An Exploratory study of Preterm Arginine INTake on biological pathways affecting immune function in infants requiring early parenteral nutrition
IRAS ID
194333
Contact name
Laura M Burgess
Contact email
Sponsor organisation
Liverpool Women's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Very premature babies require high nutritional intakes to achieve normal growth, this is rarely achieved. Making proteins (synthesis) from amino acid (AA) “building blocks” is essential during growth. Many AA play an important role in biochemical pathways as well as providing the building blocks for protein synthesis. Arginine is an example of such an AA, where deficiency has been associated with complications in premature babies such as disordered blood sugar control, increased infection and life threatening lung and bowel problems. Premature babies often lack arginine because they need feeding with parenteral (intravenous) nutrition (PN) rather than milk after birth.
Microarray is a technique that can examine the activity of thousands of genes (how much protein they are making). By looking at small blood samples from day 3 and day 10 of life we can explore what effect arginine level has on genes involved in regulating levels of nutrients in the body and its ability to fight infection. The microarray technique will allow us to explore and identify changes that occur in the way genes work during the first two weeks of life.
We will investigate the effect of current PN formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. We will also investigate the effect of supplementing arginine on these genes. We will undertake a single centre physiological study in 12 very premature infants receiving PN. 4 of these infants will be supplemented with arginine. We will record nutritional intake and routine biochemical testing data (which includes AA levels) collected over the first 10 days of life. We will take blood for analysis at prespecified intervals for microarray, ammonia and IGF-1 levels. Microarray findings will allow us to describe the effect of arginine on gene activity in preterm infants.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0271
Date of REC Opinion
1 Jun 2016
REC opinion
Further Information Favourable Opinion