Clinical Trial

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

Study acronym: proTeCt
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life. The main question it aims to answer is: Do fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth? Extremely premature babies who are receiving breathing support through a face mask will either: * Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or * Continue on face mask breathing support. All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-13; most recent amendment 2024-10-08.
Status change: Not Yet Recruiting → Recruiting 2024-10-08
Trial Details
NCT Number NCT06557551
Lead Sponsor University College Dublin
Conditions Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
Enrollment 164 participants
Start Date 2024-08-19
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-10-15