Trial of Early Surfactant Given by Thin Catheter Under Video Laryngoscopy to Extremely Premature Infants to Reduce Breathing Tube Use Within 3 Days of Birth

What this Trial Is About

Researchers are studying whether giving surfactant through a thin endotracheal catheter to extremely premature babies right after birth can reduce the need for mechanical ventilation in the first three days of life. The trial focuses on infants born before 28 weeks of gestation who are at risk of respiratory distress syndrome and usually receive breathing support with continuous positive airway pressure CPAP. The study compares this new less-invasive surfactant method under video laryngoscopy guidance to standard face mask breathing support without surfactant. In the intervention group, at or after 5 minutes of life, a thin catheter is inserted into the babys windpipe using video laryngoscopy to deliver surfactant, then immediately removed so the baby continues with face mask breathing support. The control group continues with face mask breathing support only. The surfactant doses vary by gestational age, and video laryngoscopy helps ensure correct catheter placement. This trial aims to see if early surfactant given this way reduces the need for ventilation and related complications. Participants are closely monitored for whether they require intubation and mechanical ventilation within the first 72 hours of life. Additional measures include the success of catheter insertion, heart rate changes, respiratory support needed, and various health outcomes up to four months or hospital discharge. The study tracks complications like bronchopulmonary dysplasia, brain hemorrhages, and other serious conditions. Overall, the trial evaluates whether this new surfactant delivery method improves breathing support outcomes in extremely premature infants.

Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial