Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
University College Dublin
164 participants
Aug 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria1
- • 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 )
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Interventions
Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life
Locations(1)
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NCT06557551