Preterm Arginine INTake Study

NCT02751437 | Completed

• 1 other identifier: LWH1077
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

preterm; arginine; immune function; nutrition

Outcome Measures

Primary Outcomes (1)

• The pattern of alteration in gene expression between day 3 and day 10 in arginine deficient preterm infants after supplementation with arginine.

  The changes in gene expression will be compared with those seen in unsupplemented infants, with and without arginine deficiency. The genes of interest are those involved in T-cell function and associated inflammatory pathways.

  Samples on Day 3 and Day 10 of life

Secondary Outcomes (4)

• The pattern of alteration in gene expression associated with biological pathways known to be associated with NEC.

  Day 3 and Day 10 of life

• The pattern of alteration in gene expression associated with biological pathways known to be involved in arginine metabolism

  Day 3 and Day 10 of life

• The pattern of alteration in gene expression associated with biological pathways that are related to the IGF-1-insulin axis

  Day 3 and Day 10 of life

• To validate if high ammonia levels (as a measure of functional arginine deficiency) are linked with impaired T-cell function and associated inflammatory pathways

  Day 3 of life

Study Arms (3)

Low Arginine unsupplemented

NO INTERVENTION

These infants identified as having low blood arginine levels will receive standard care.

Low Arginine supplemented

EXPERIMENTAL

These infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life.

Dietary Supplement: Arginine

Normal Arginine

NO INTERVENTION

These infants identified as having normal arginine levels will receive standard care.

Interventions

Arginine DIETARY_SUPPLEMENT

Low Arginine supplemented

Eligibility Criteria

• Age: 23 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth

You may not qualify if:

• Infants who are unlikely to survive the first week after birth.
• Infants with early onset infection (\<72 hours)
• 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

Study Sites (1)

Liverpool Women's Hospital

Liverpool, L8 7SS, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Arginine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Colin Morgan, MBBS BSc MD

  Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 26, 2016
• Study Start: August 5, 2016
• Primary Completion: July 31, 2017
• Study Completion: March 31, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)