Exploring the effects of arginine supplementation on immune function in preterm infants
An Exploratory Study of Increased Preterm Arginine INTake on Biological Pathways Affecting Immune Function in Infants Requiring Early Parenteral Nutrition
This study tests if adding arginine to the nutrition of very premature infants can help improve their immune system.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 22 Weeks to 29 Weeks |
| Sex | All |
| Sponsor | Liverpool Women's NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT05299112 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of arginine supplementation on immune function in very premature infants receiving parenteral nutrition. A total of 24 infants born at or transferred to Liverpool Women's Hospital will be enrolled, with 16 receiving additional arginine in their nutrition. Blood samples will be collected at specified intervals to analyze gene expression and nutritional markers over the first 30 days of life. The primary objective is to assess changes in gene expression related to immune function in infants supplemented with arginine compared to those who are not.
Who should consider this trial
Good fit: Ideal candidates are infants born before 29 weeks of gestation or weighing less than 1200 grams who are admitted to the Neonatal Unit at Liverpool Women's Hospital.
Not a fit: Infants unlikely to survive the first week after birth or those with serious metabolic or liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance immune function in preterm infants, potentially improving their health outcomes.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in enhancing nutritional support for preterm infants, though this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born \<29 weeks' gestation * and/or with birthweight \<1200g * Admitted to the Neonatal Unit at Liverpool Women's Hospital within 48 hours of birth. Exclusion Criteria: * Infants who are unlikely to survive the first week after birth. * 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
Where this trial is running
Liverpool, Merseyside
- Liverpool Women's Hospital — Liverpool, Merseyside, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.