NCT06557551 Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
| NCT ID | NCT06557551 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Dublin |
| Condition | Infant, Newborn, Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-08-19 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 )
Contact & Investigator
Colm PF O'Donnell
PRINCIPAL INVESTIGATOR
National Maternity Hospital, University College Dublin
Frequently Asked Questions
Who can join the NCT06557551 clinical trial?
This trial is open to participants of all sexes, up to 30 Minutes, studying Infant, Newborn, Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557551 currently recruiting?
Yes, NCT06557551 is actively recruiting participants. Contact the research team at codonnell@nmh.ie for enrollment information.
Where is the NCT06557551 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06557551 clinical trial?
NCT06557551 is sponsored by University College Dublin. The principal investigator is Colm PF O'Donnell at National Maternity Hospital, University College Dublin. The trial plans to enroll 164 participants.