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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• Infants of any sex born before 28 weeks of gestation

• Clinicians plan to provide intensive care

• Consent for their participation provided by parent(s)/guardian(s) before their birth

Locations
Other Locations
Ireland
National Maternity Hospital
RECRUITING
Dublin
Contact Information
Primary
Colm PF O'Donnell, MB PhD
codonnell@nmh.ie
35316373100
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 164
Treatments
Experimental: Thin catheter surfactant
At or after 5 minutes of life, participants will have a thin endotracheal catheter (Surfcath, Vygon, Ecouen, France) inserted under video laryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany), through which they will receive surfactant (Curosurf, Chiesi Farmaceutici, Parma, Italy - 120mg for infants \< 26 weeks, 240mg for infants 26 - 27+6 weeks). The catheter will then be removed, and they will continue on face mask breathing support.
No_intervention: Standard care
Participants will continue on face mask breathing support.
Related Therapeutic Areas
Sponsors
Leads: University College Dublin

This content was sourced from clinicaltrials.gov