Preterm Arginine INTake Study

NCT02751437 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-08-20

No results posted yet for this study

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.

Conditions

  • Preterm Infant Nutrition and Immune Function

Interventions

DIETARY_SUPPLEMENT

Arginine

Sponsors & Collaborators

  • Liverpool Women's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Colin Morgan, MBBS BSc MD · Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-05
Primary Completion
2017-07-31
Completion
2018-03-31

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 NCT02751437 on ClinicalTrials.gov