An Exploratory Study of Increased Preterm Arginine INTake (PAINT18)

NCT05299112 | Unknown

• 1 other identifier: LWH1213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm; Arginine; Immune function; Nutrition

Outcome Measures

Primary Outcomes (1)

• Gene expression via Illumina RNA sequencing

  RNA will be extracted from whole blood and sent for Illumina RNA sequencing. These sequences are then mapped to reference gene sets for gene expression analysis. The pattern of alteration in gene expression between days 3 and 10 in arginine deficient preterm infants after correction of their deficiency by supplementation with arginine will be analysed. The changes in gene expression will be compared with those seen in unsupplemented infants. The genes of interest are those involved in T-cell function and associated inflammatory pathways. Statistical pathway analysis will be used to identify these genes and their relationship with key biological pathways.

  Day 3 and 10 of life

Secondary Outcomes (9)

• Gene expression via Illumina RNA sequencing

  Days 3, 10 and 30 of life

• Gene expression via Illumina RNA sequencing

  Day 3, 10 and 30 of life

• Gene expression via Illumina RNA sequencing

  Day 3, 10 and 30 of life

• Blood ammonia levels

  Day 3, 10 and 30 of life

• Plasma arginine levels

  Day 3, 10 and 30 of life

Study Arms (2)

Standard parenteral nutrition

NO INTERVENTION

These infants will form the control group and will receive standard parenteral nutrition. They will be sub-stratified into infants \<27 weeks and infants \>27 weeks gestation.

Arginine supplementation

EXPERIMENTAL

These infants will form the intervention group and will receive parenteral nutrition with additional arginine (18% of amino acid) for up to 14 days of life. They will be sub-stratified into infants \<27 weeks and infants \>27 weeks gestation.

Dietary Supplement: Arginine

Interventions

Arginine DIETARY_SUPPLEMENT

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

Arginine supplementation

Eligibility Criteria

• Age: 22 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born \<29 weeks' gestation
• and/or with birthweight \<1200g
• Admitted to the Neonatal Unit at Liverpool Women's Hospital within 48 hours of birth.

You may not qualify if:

• Infants who are unlikely to survive the first week after birth.
• Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction
• Parents who are unable to give informed consent

Sponsors & Collaborators

• Liverpool Women's NHS Foundation Trust: lead
• University of Liverpool: collaborator
• University of California, Davis: collaborator

Study Sites (1)

Liverpool Women's Hospital

Liverpool, Merseyside, L8 7SS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth; Malnutrition

Interventions

Arginine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is not blinded or randomized.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be parallel assignment of supplemented parenteral nutrition (PN) and standard parenteral nutrition dependent upon stock availability of intervention PN.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 28, 2022
• Study Start: December 7, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 30, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)