Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
Launched by UNIVERSITY COLLEGE DUBLIN · Aug 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ProTeCt Trial is researching a treatment for extremely premature babies who are born before 28 weeks of pregnancy. The main goal of the study is to find out if giving a special substance called surfactant through a thin tube in the baby's windpipe, shortly after birth, can help these babies breathe better and reduce the need for more invasive breathing support within the first three days of life. Surfactant is important because it helps keep the tiny air sacs in the lungs open, making it easier for the baby to breathe.
To be eligible for this trial, babies must be born before 28 weeks of gestation and require intensive care. Parents or guardians must give consent for their participation before the baby is born. During the trial, some babies will receive the surfactant through a thin catheter inserted into their windpipe under video guidance, while others will continue receiving breathing support through a face mask. All babies will be carefully monitored to see if they need additional breathing support within the first 72 hours after birth. This study aims to provide important information that could help improve care for premature infants in the future.
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • 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
- • Exclusion criteria
- • • Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD/PFO/VSD/PDA )
About University College Dublin
University College Dublin (UCD) is a leading research institution in Ireland, renowned for its commitment to advancing health sciences through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, UCD integrates cutting-edge scientific inquiry with practical applications to enhance patient care and public health outcomes. The university's clinical trial initiatives are bolstered by state-of-the-art facilities, a diverse pool of research expertise, and robust partnerships with healthcare providers and industry stakeholders. UCD is dedicated to fostering a culture of ethical research practices and ensuring the highest standards of scientific rigor in all clinical trials it sponsors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dublin, None Selected, Ireland
Patients applied
Trial Officials
Colm PF O'Donnell
Principal Investigator
National Maternity Hospital, University College Dublin
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported