Preterm Arginine INTake Study (PAINT)
Primary Purpose
Preterm Infant Nutrition and Immune Function
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Arginine
Sponsored by

About this trial
This is an interventional other trial for Preterm Infant Nutrition and Immune Function focused on measuring preterm, arginine, immune function, nutrition
Eligibility Criteria
Inclusion Criteria:
- Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth
Exclusion Criteria:
- 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
Sites / Locations
- Liverpool Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
No Intervention
Arm Label
Low Arginine unsupplemented
Low Arginine supplemented
Normal Arginine
Arm Description
These infants identified as having low blood arginine levels will receive standard care.
These infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life.
These infants identified as having normal arginine levels will receive standard care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The pattern of alteration in gene expression associated with biological pathways known to be associated with NEC.
The pattern of alteration in gene expression associated with biological pathways known to be involved in arginine metabolism
The pattern of alteration in gene expression associated with biological pathways that are related to the IGF-1-insulin axis
To validate if high ammonia levels (as a measure of functional arginine deficiency) are linked with impaired T-cell function and associated inflammatory pathways
Full Information
NCT ID
NCT02751437
First Posted
March 21, 2016
Last Updated
August 16, 2018
Sponsor
Liverpool Women's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02751437
Brief Title
Preterm Arginine INTake Study
Acronym
PAINT
Official Title
Effect of Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 5, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Women's NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant Nutrition and Immune Function
Keywords
preterm, arginine, immune function, nutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Arginine unsupplemented
Arm Type
No Intervention
Arm Description
These infants identified as having low blood arginine levels will receive standard care.
Arm Title
Low Arginine supplemented
Arm Type
Experimental
Arm Description
These infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life.
Arm Title
Normal Arginine
Arm Type
No Intervention
Arm Description
These infants identified as having normal arginine levels will receive standard care.
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine
Primary Outcome Measure Information:
Title
The pattern of alteration in gene expression between day 3 and day 10 in arginine deficient preterm infants after supplementation with arginine.
Description
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.
Time Frame
Samples on Day 3 and Day 10 of life
Secondary Outcome Measure Information:
Title
The pattern of alteration in gene expression associated with biological pathways known to be associated with NEC.
Time Frame
Day 3 and Day 10 of life
Title
The pattern of alteration in gene expression associated with biological pathways known to be involved in arginine metabolism
Time Frame
Day 3 and Day 10 of life
Title
The pattern of alteration in gene expression associated with biological pathways that are related to the IGF-1-insulin axis
Time Frame
Day 3 and Day 10 of life
Title
To validate if high ammonia levels (as a measure of functional arginine deficiency) are linked with impaired T-cell function and associated inflammatory pathways
Time Frame
Day 3 of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
29 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Morgan, MBBS BSc MD
Organizational Affiliation
Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool Women's Hospital
City
Liverpool
ZIP/Postal Code
L8 7SS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be made available
Learn more about this trial
Preterm Arginine INTake Study
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