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Safety and PK-PD Study of Oral L-CIT in Preterm Infants with BPD±PH and NEC
Sponsor: The Hospital for Sick Children
Summary
The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post surgical NEC and BPD±PH.
Official title: A Phase I, Safety and Pharmacokinetics/pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants with BPD±PH and NEC
Key Details
Gender
All
Age Range
1 Month - 6 Months
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-11-01
Completion Date
2028-03
Last Updated
2025-01-16
Healthy Volunteers
No
Interventions
L-Citrulline
Citrulline is a nonessential amino acid made in the small intestine, occurs naturally in the body, and is believed to help reduce inflammation.L-CIT is a part of the urea cycle, produced as a by-product along with nitric oxide (NO).
Locations (1)
The Hospital For Sick Children
Toronto, Ontario, Canada