An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse
NCT ID: NCT05306925
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
48 participants
INTERVENTIONAL
2022-04-14
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term/near term infants. 16 of these infants (8 preterm and 8 term/near term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Exploratory Study of Increased Preterm Arginine INTake (PAINT18)
NCT05299112
Administration of Arginine Supplementation in Preterm Infants
NCT01336998
Prenatal Antibiotics and Breast Milk / Neonatal IgA
NCT05813184
Infant Immune Response to Bacterial Infection
NCT00546195
Preterm Immune System Development and Response to Immunization
NCT05266664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Arginine Supplementation and the Postoperative Immune REsponse (ASPIRE) in neonates
Population:
Preterm infants \<30 weeks gestation requiring a laparotomy/major bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge before discharge ; Term and near term infants (born \>35 weeks gestation) requiring a laparotomy/major bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days PN).
Number of infants:
48 infants (completing the study) will be recruited over approximately 24-36 months: 24 in the preterm group and 24 in the term group.
Number of sites:
Two sites - Alder Hey Children's Hospital (AHCH) and Liverpool Women's Hospital (LWH) under the umbrella of the Neonatal Partnership. Eligible infants will undergo surgery at AHCH and will receive early postoperative care at either AHCH or LWH
Study duration:
Informed consent will take place preoperatively where possible, or within 5 days of surgery or NEC diagnosis. In the term group, antenatal recruitment will be attempted. The first study related blood sample will be taken as soon as possible postoperatively following consent with the last sample taken on day 30 post-operatively. Other study assessments reflect those routinely performed in preterm infants receiving parenteral nutrition (PN).
Study intervention:
All infants will receive standard clinical treatment. 8 preterm and 8 term infants will receive PN as determined by local clinical guidelines (6.3 or 8.4% arginine content). 8 term infants and 8 preterm infants will receive PN as determined by local clinical guidelines (6.3 or 8.4% arginine content) and enteral arginine supplementation. Enteral L-arginine will start with the first enteral feedings: starting 0.75mmol/kg/day, doubled to 1.5mmol/kg (261mg/kg/day) when reaching 40% of enteral feeds. 8 preterm and 8 term infants will receive PN with an additional arginine supplement and oral supplementation. PN supplementation will aim to achieve up to 18% arginine intake (allocated according to intervention PN stock availability) and will be titrated against oral supplementation during the transition to enteral feeds.
Primary objective:
To examine the changes in gene expression present in arginine supplemented infants between day 3 and day 10 post-operatively. Thus will be done via illumina RNA sequencing and statistical pathway analysis. The changes in gene expression will be compared with those seen between day 3 and day 10 in unsupplemented preterm and term infants. The genes of interest are those involved in immune function and 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 determine the changes in metabolomic profiles of these infants during the first 30 days postoperatively.
3. Growth and body composition data during study period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard parenteral nutrition
These infants will form the control group and will receive standard parenteral nutrition. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
No interventions assigned to this group
Arginine supplementation (combined)
These infants will form an intervention group and will receive parenteral nutrition with additional arginine (up to 18% of amino acid make-up) for up to 14 days post-op and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
Arginine
The intervention infants will receive either parenteral nutrition which contains additional arginine (up to 18% arginine content) or a separate arginine infusion to provide up to 18% arginine. This is in comparison to standard parenteral nutrition which has an arginine content of 6.3%.
Arginine supplementation (oral only)
These infants will form an intervention group and will receive standard parenteral nutrition and oral arginine supplementation up to 30 days post-op. They will be sub-stratified into gestational brackets - preterm (born \<30 weeks) and term/near term.
Arginine
The intervention infants will receive either parenteral nutrition which contains additional arginine (up to 18% arginine content) or a separate arginine infusion to provide up to 18% arginine. This is in comparison to standard parenteral nutrition which has an arginine content of 6.3%.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arginine
The intervention infants will receive either parenteral nutrition which contains additional arginine (up to 18% arginine content) or a separate arginine infusion to provide up to 18% arginine. This is in comparison to standard parenteral nutrition which has an arginine content of 6.3%.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Term and near term infants (born\>35 weeks gestation) requiring laparotomy/major bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days of PN)
Exclusion Criteria
* 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
22 Weeks
44 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liverpool
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom
Liverpool Women's Hospital
Liverpool, Merseyside, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emma Rutherford
Role: primary
Louise Hardman
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UoL001648
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.