Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

This study is specifically for babies who are born very prematurely, usually between 26 and 33 weeks of pregnancy, and weigh 2000 grams (about 4 pounds 6 ounces) or less. They must be born at the hospital where the study is taking place and be very young – only 1 to 24 hours old – when they join.

To be considered, babies must already be receiving some gentle breathing support (like nCPAP or NIV) and show signs of Respiratory Distress Syndrome on an X-ray or ultrasound. The breathing support they are on should be at a certain level, and their oxygen levels also need to be within a specific range.

However, some babies cannot join the study. For example, if they have certain serious health problems like a major birth defect, a collapsed lung (pneumothorax), or if they received lung-helper medicine before joining. Also, babies who had a very difficult birth, needed CPR, or were part of a triplet (or more) birth are not eligible. These rules help make sure the study is safe and that the results are clear.

If your baby takes part in this study, they will either receive the new medicine APC-0101 or continue with the standard gentle breathing support (which is the 'control' group). You won't know which group your baby is in, and neither will the doctors, which helps make the study results fair. The medicine is given by inhalation.

Initially, babies will be closely monitored until they reach what would have been 40 weeks of pregnancy or until they go home from the hospital, whichever happens first. After that, there will be follow-up appointments. These follow-up visits will continue until your child is 24 months old (2 years old), measured from their expected due date. During these visits, doctors will check your child's breathing, growth, and overall development to see how they are doing. The total time your child is involved in the study is about two years.