This study is looking at a treatment called APC-0101 for premature babies who have Respiratory Distress Syndrome (RDS), a breathing problem. APC-0101 is a combination of a special lung medicine (SF-RI 1 surfactant) and a delivery system. We want to see if APC-0101, given with breathing support (nCPAP/NIV), is safe and effective compared to breathing support alone. Babies between 1 and 24 hours old, born at 26 to 33 weeks gestational age, weighing 2000 grams or less, and born at the study hospital can participate. The main goal is to see if babies avoid certain problems within the first 7 days of life. This study plans to enroll 520 babies.

Study design

This is a randomized, blinded study where some babies receive APC-0101 and others receive a sham treatment (empty vial) with the same breathing support. It is planned for 520 participants.

What's involved

Participants will have their breathing support interface changed and will receive either APC-0101 or a sham treatment. They will be followed until 40 weeks post-menstrual age or discharge from the NICU, and then for 24 months corrected age.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed until 40 weeks post-menstrual age or NICU discharge, and then through 24 months corrected age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.