Preterm Arginine INTake Study
Condition: Preterm Infant Nutrition and Immune Function
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The investigators will explore the effect of current intravenous feeding (parenteral
      nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body
      nutrition and fighting infection in premature babies. They will also investigate the effect
      of supplementing arginine on these genes. The investigators will undertake a single centre
      exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants
      will be supplemented with arginine. The investigators will record nutritional intake and
      routine biochemical testing data (which includes amino acid levels) collected over the first
      10 days of life. They will take blood for analysis at prespecified intervals for microarray,
      ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the
      effect of arginine on gene activity in preterm infants.
    

Detailed description: 
      Title:

      Effect of Preterm Arginine INTake on biological pathways affecting immune function in infants
      requiring early parenteral nutrition (PAINT)

      Population: Preterm infants <29 weeks gestation

      Number of infants: 12 infants (completing the study) will be recruited over approximately 12
      months

      Number of sites: One. Infants will be born at Liverpool Women's Hospital (LWH) or transferred
      to LWH within 48 hours of birth.

      Study duration: Informed consent will take place within 72 hours of birth. The first study
      related blood sample will be taken at this point and will determine arginine status (using
      blood ammonia and arginine levels) with the last sample taken on postnatal day 10. Other
      study assessments reflect those routinely performed in preterm infants receiving parenteral
      nutrition (PN).

      Study intervention: All infants will receive standard clinical treatment. The study will
      involve 4 infants with normal arginine status, and 8 infants with evidence of arginine
      deficiency. Of these, 4 infants will receive standard PN and the study intervention of an
      additional arginine infusion of 10mg/kg/hr from day 3 until day 10, the other 8 infants will
      receive standard PN only.

      Primary objective: To determine the alterations in gene expression present in infants <29
      weeks gestation (and shown to be arginine deficient on day 3) between day 3 and day 10 in
      infants receiving additional arginine supplementation. The changes in gene expression will be
      compared with those seen between day 3 and day 10 in unsupplemented infants, with and without
      arginine deficiency. The genes of interest are those involved in T-cell function and
      associated inflammatory pathways.

      Secondary objectives:

        1. To explore other biological pathways i) known to be involved in the pathogenesis of
           necrotising enterocolitis ii) involved in arginine metabolism iii) that are related to
           the insulin-IGF-I axis

        2. To assess whether there is an association between high ammonia levels (as a measure of
           functional arginine deficiency) and T-cell dysfunction and associated inflammatory
           pathways.
    

Intervention name(s): Arginine
Intervention type(s): Dietary Supplement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: preterm; arginine; immune function; nutrition