About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Thin catheter surfactant
Other interventionSurfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life
Treatment groups
Trial outcomes
Primary outcomes
Number of participants intubated in the first 72 hours of life
Endotracheal intubation 1. in the Delivery Room for apnoea or bradycardia despite mask PPV; or 2. in the Neonatal Intensive Care Unit, for 2 or more of * worsening clinical signs respiratory distress * oxygen requirement \> 30% for \>30 mins to keep oxygen saturation (SpO2) \>90% * pH \< 7.2 on 2 blood gases 30 minutes apart * PCO2 \>9kPa on 2 blood gases 30 minutes apart * recurrent mask PPV for apnoea Participants reach the primary outcome if they are intubated with an endotracheal tube (ETT) for mechanical ventilation, with an ETT for surfactant and mechanical ventilation, with an ETT for surfactant alone, or with a thin catheter for surfactant alone
Secondary outcomes
Number of participants in whom the thin catheter is seen on video laryngoscopy to be successfully inserted at first attempt (intervention group only)
Success at first thin catheter insertion attempt (intervention group only)
Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR)
Bradycardia (HR \< 100bpm) in the DR
Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR
Mask PPV in the DR
Number of participants who undergo endotracheal intubation in the DR
Endotracheal intubation in the DR
Sponsors and contacts
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