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Preterm Arginine INTake Study (PAINT)

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ClinicalTrials.gov Identifier: NCT02751437
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Liverpool Women's NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Preterm Infant Nutrition and Immune Function Dietary Supplement: Arginine Not Applicable

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:

  1. 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
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
Actual Study Start Date : August 5, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Low Arginine unsupplemented
These infants identified as having low blood arginine levels will receive standard care.
Experimental: Low Arginine supplemented
These infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life.
Dietary Supplement: Arginine
No Intervention: Normal Arginine
These infants identified as having normal arginine levels will receive standard care.



Primary Outcome Measures :
  1. The pattern of alteration in gene expression between day 3 and day 10 in arginine deficient preterm infants after supplementation with arginine. [ Time Frame: Samples on Day 3 and Day 10 of life ]
    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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751437


Locations
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United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS
Sponsors and Collaborators
Liverpool Women's NHS Foundation Trust
Investigators
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Study Director: Colin Morgan, MBBS BSc MD Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS

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Responsible Party: Liverpool Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02751437     History of Changes
Other Study ID Numbers: LWH1077
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be made available

Keywords provided by Liverpool Women's NHS Foundation Trust:
preterm
arginine
immune function
nutrition

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications