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

Launched by THE HOSPITAL FOR SICK CHILDREN · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effects of a supplement called L-CIT in preterm infants who are at risk for certain lung and gut conditions, specifically Bronchopulmonary Dysplasia (BPD) and Necrotizing Enterocolitis (NEC). The goal is to see if giving L-CIT can help prevent inflammation that these infants might experience due to low levels of a substance in their blood. The trial is currently looking for participants, including infants born before 30 weeks of pregnancy who are either recovering from surgery for NEC or have BPD with pulmonary hypertension (high blood pressure in the lungs).

To be part of this study, infants need to be at least 34 weeks old and require certain types of breathing support. Parents or guardians will need to provide written consent for their child to participate. If eligible, families can expect close monitoring and care as part of the trial. It's important to note that infants with specific heart conditions or severe infections, among other factors, will not be included in the study to ensure their safety. This trial aims to find out if L-CIT can help improve the health outcomes of these vulnerable infants.

Gender

ALL

Eligibility criteria

• 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

Trial Officials