RecruitingNot ApplicableNCT05636397

Safety and PK-PD Study of Oral L-CIT in Preterm Infants with BPD±PH and NEC

A Phase I, Safety and Pharmacokinetics/pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants with BPD±PH and NEC


Sponsor

The Hospital for Sick Children

Enrollment

60 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This study tests an oral form of L-citrulline (a natural amino acid) in premature babies who have a serious lung condition called bronchopulmonary dysplasia (BPD), sometimes with high blood pressure in the lungs. It also includes babies with a serious gut condition called NEC (necrotizing enterocolitis). The goal is to assess safety and how the drug is processed in very small, fragile patients. **You may be eligible if...** - Your baby was born at 30 weeks or earlier - Your baby is now at a post-menstrual age of at least 34 weeks - Your baby has bronchopulmonary dysplasia (with or without high blood pressure in the lungs) or necrotizing enterocolitis - Your baby is still on breathing support **You may NOT be eligible if...** - Your baby has a congenital heart defect (with limited exceptions) - Your baby has other conditions making the study too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTL-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

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NCT05636397


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