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An Exploratory Study of Increased Preterm Arginine INTake (PAINT18)

NCT05299112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-09-06

No results posted yet for this study

Summary

PAINT18 is a nutrition study focusing on the effect of arginine supplementation on immune function in preterm infants.

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. The investigators will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 24 very premature infants receiving PN. 16 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 30 days of life. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and IGF-1 levels. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in preterm 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.

Conditions

  • Preterm
  • Nutritional Deficiency
  • Immune System and Related Disorders

Interventions

DIETARY_SUPPLEMENT

Arginine

The intervention parenteral nutrition contains additional arginine (18% arginine content) as compared to standard parenteral nutrition (6.3% arginine content).

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Liverpool Women's NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2023-06-07
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299112 on ClinicalTrials.gov