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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Arm 1: BPD±PH: Who May Qualify: - Born ≤ 30 weeks at birth - Post-menstrual age (PMA) ≥ 34 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 - Informed written consent (parents/substitute decision maker) Who Should NOT Join This Trial: - 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 - Any other condition that, in the opinion of the investigator, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant. Arm 2: surgical NEC Inclusion Criteria - Born ≤ 30 weeks at birth - Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery) - Tolerating 30 ml/kg/day of enteral feeds - On invasive or non-invasive ventilation (NIPPV/nCPAP) with RSS \>2.0 for \> 12hours/day for at least 48 hours, 10-14 days post surgery - Informed written consent (parents/substitute decision maker) - Considered medically stable by clinical team Who Should NOT Join This Trial: - Congenital heart disease (except small ASD, small VSD and non hsPDA) - Pulmonary vein stenosis - Concurrent sepsis with hemodynamic instability - Likely to die within next 7 days - Other condition significantly affecting pulmonary function independent of prematurity or NEC Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Arm 1: BPD±PH: Inclusion Criteria: * Born ≤ 30 weeks at birth * Post-menstrual age (PMA) ≥ 34 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 * Informed written consent (parents/substitute decision maker) Exclusion Criteria: * 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 * Any other condition that, in the opinion of the investigator, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant. Arm 2: surgical NEC Inclusion Criteria * Born ≤ 30 weeks at birth * Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery) * Tolerating 30 ml/kg/day of enteral feeds * On invasive or non-invasive ventilation (NIPPV/nCPAP) with RSS \>2.0 for \> 12hours/day for at least 48 hours, 10-14 days post surgery * Informed written consent (parents/substitute decision maker) * Considered medically stable by clinical team Exclusion Criteria: * Congenital heart disease (except small ASD, small VSD and non hsPDA) * Pulmonary vein stenosis * Concurrent sepsis with hemodynamic instability * Likely to die within next 7 days * Other condition significantly affecting pulmonary function independent of prematurity or NEC

Treatments Being Tested

DIETARY_SUPPLEMENT

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