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

Pulmonary Hypertension BPD - Bronchopulmonary Dysplasia NEC

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

Inclusion Criteria12

Arm 1: BPD±PH:
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)
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 Criteria11

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
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

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).