💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Arm 1: BPD±PH:
Inclusion Criteria:
* 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
* 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 50 ml/kg/day of enteral feeds
* 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
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