Preterm Arginine INTake study - PAINT 18
Research type
Research Study
Full title
An exploratory study of increased Preterm Arginine INTake on biological pathways affecting immune function in infants requiring early parenteral nutrition
IRAS ID
253730
Contact name
Colin Morgan
Contact email
Sponsor organisation
Liverpool Women's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 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.
This is the third study in a series of exploratory physiological studies investigating the effect of current PN and new formulations with additional arginine on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. We will undertake a single centre physiological study in 24 very premature infants receiving PN. 16 of these infants will receive extra arginine in their PN and 8 infants will serve as a control group. We will record nutritional intake and routine biochemical testing data (which includes AA levels) collected over the first 30 days of life. We will take extra blood for analysis at prespecified intervals (days 3, 10 and 30) for 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.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0044
Date of REC Opinion
14 Feb 2020
REC opinion
Favourable Opinion