Preterm Infant Nutrition and Immune FunctionPAINTNCT02751437
Preterm Arginine INTake Study
A study testing Arginine in people with Preterm Infant Nutrition and Immune Function, run by Liverpool Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 29 weeks
- Conditions the study is for
- Preterm Infant Nutrition and Immune Function
- What is being tested?
- Arginine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
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.
Read the 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.
- Being tested
- Arginine
- Keywords
- preterm, arginine, immune function, nutrition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Arginine |
| Normal Arginine | No intervention | These infants identified as having normal arginine levels will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 3 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start5 Aug 2016
- Primary completion31 Jul 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant Nutrition and Immune FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Women's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Morgan, MBBS BSc MD, Study director, Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751437
- Sponsor's protocol ID
- LWH1077
- Acronym
- PAINT
- Status last verified
- Aug 2018
- First submitted
- 21 Mar 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No IPD will be made available
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02751437
- Acronym / sponsor ID
- PAINT / LWH1077
- Keywords
- preterm, arginine, immune function, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Liverpool Women's NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Arginine unsupplemented | No intervention | –These infants identified as having low blood arginine levels will receive standard care. |
| Low Arginine supplemented | Experimental | Dietary Supplement: ArginineThese infants identified as having low arginine levels will receive an additional arginine infusion between days 3 and 10 of life. |
| Normal Arginine | No intervention | –These infants identified as having normal arginine levels will receive standard care. |
Who may qualify
- Ages
- 23 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants born between 23 and 29 completed weeks gestation and admitted to the neonatal unit within 48 hours of birth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arginine | Dietary supplement | Low Arginine supplemented |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No. No IPD will be made available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Morgan, MBBS BSc MD study director
Neonatal Unit, Liverpool Women's Hospital, Crown St, Liverpool, L8 7SS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine in people with Preterm Infant Nutrition and Immune Function, run by Liverpool Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.