Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorThe Hospital for Sick Children
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Born ≤ 30 weeks at birth
Post-menstrual age (PMA) ≥ 32 weeks
Echocardiographic evidence of PH for infants with BPD+PH.
On invasive or non-invasive ventilation with RSS >2.0 for >12hours/day for at least 48 hours as an early predictor of evolving BPD
Disqualifiers
Congenital Heart Disease [Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)]
Infants with pulmonary vein stenosis
Concurrent sepsis with hemodynamic instability
Infants considered likely to die within next 7 days
Trial design
Design model
Parallel
Treatments tested in this trial
L-Citrulline
Dietary supplementCitrulline 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).
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: BPD±PHExperimental treatment 1 intervention
Group B: Surgical NECExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of oral L-Citrulline administration
The number of patients with adverse events (AE) as a measure of safety and tolerability
Time frame
5 yearsSecondary outcomes
1
Association of blood pressure as one of the PD outcomes with maximum L-CIT concentration (Cmax)
Blood pressure of the study participants will be associated with PK measures of L-CIT exposure i.e. Cmax using univariate correlation approaches. The investigator will then attempt to construct a PK/PD model to link PK and PD measures found to be of significance during the univariate screen. Future larger studies will then be used to examine these relationships with adequately powered studies.
Time frame
5 years2
Association of stoma or nasogastric output as one of the PD outcomes with maximum L-CIT concentration (Cmax)
Stoma or nasogastric output of the study participants will be associated with PK measures of L-CIT exposure i.e. Cmax using univariate correlation approaches. The investigator will then attempt to construct a PK/PD model to link PK and PD measures found to be of significance during the univariate screen. Future larger studies will then be used to examine these relationships with adequately powered studies.
Time frame
5 years3
Association of stool output as one of the PD outcomes with maximum L-CIT concentration (Cmax)
Stool output from the study participants will be associated with PK measures of L-CIT exposure i.e. Cmax using univariate correlation approaches. The investigator will then attempt to construct a PK/PD model to link PK and PD measures found to be of significance during the univariate screen. Future larger studies will then be used to examine these relationships with adequately powered studies.
Time frame
5 years4
Association of blood pressure with the area under the concentration time curve (AUC) for L-CIT
Blood pressure of the study participants will be associated with PK measures of L-CIT exposure i.e. Area under Concentration time curve (AUC) using univariate correlation approaches. The investigator will then attempt to construct a PK/PD model to link PK and PD measures found to be of significance during the univariate screen.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov