Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants at Birth: the proTeCt Trial
NCT Number: NCT06557551
Acronym: proTeCt
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infant, Newborn, Diseases|Prematurity|Prematurity; Extreme|Respiratory Distress Syndrome in Premature Infant
Interventions: OTHER: Thin catheter surfactant
Sponsor: University College Dublin
Sex: ALL
Age: CHILD
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2027-02-28
Locations: National Maternity Hospital, Dublin, None Selected, D02 YH21, Ireland

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.

Primary Outcome Measures: 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, First 72 hours of life
Secondary Outcome Measures: 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), 30 minutes|Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR), Bradycardia (HR \< 100bpm) in the DR, 30 minutes|Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR, Mask PPV in the DR, 30 minutes|Number of participants who undergo endotracheal intubation in the DR, Endotracheal intubation in the DR, 30 minutes|Number of participants who receive chest compressions in the DR, Chest compressions in the DR, 30 minutes|Number of participants who receive adrenaline in the DR, Adrenaline administration in the DR, 30 minutes|Number of participants who receive volume expansion in the DR, Volume expansion in the DR, 30 minutes|Number of participants who are itubated at any time during hospitalisation, Intubation at any time during hospitalisation, 4 months or before hospital discharge, whichever occurs first|Number if participants who receive intratracheal surfactant post intervention, Treatment with intratracheal surfactant, post prophylactic delivery room TC surfactant in the intervention group, or at any time in the control group, 4 months or before hospital discharge, whichever occurs first|Number of participants who have pneumothorax drained with needle aspiration or chest drain insertion, Pneumothorax drained with needle aspiration or chest drain insertion, 4 months or before hospital discharge, whichever occurs first|Duration of mechanical ventilation (days), Duration of mechanical ventilation (days), 4 months or before hospital discharge, whichever occurs first|Duration of any respiratory support (ventilation, CPAP, HFNC) (days), Duration of any respiratory support (ventilation, CPAP, HFNC) (days), 4 months or before hospital discharge, whichever occurs first|Duration of oxygen therapy (days), Duration of oxygen therapy (days), 4 months or before hospital discharge, whichever occurs first|Number of participants who have bronchopulmonary dysplasia (BPD) among survivors to 36 weeks, Bronchopulmonary dysplasia (BPD) among survivors to 36 weeks, 4 months or before hospital discharge, whichever occurs first|Number of participants who receive postnatal steroids for BPD, Treatment with systemic postnatal corticosteroids (e.g. dexamethasone) for respiratory insufficiency, 4 months or before hospital discharge, whichever occurs first|Number of participants with severe intraventricular haemorrhage (IVH) (grade III or IV) on cranial ultrasound, Severe intraventricular haemorrhage (IVH) (grade III or IV) on cranial ultrasound, 4 months or before hospital discharge, whichever occurs first|Number of participants with cystic periventricular leukomalacia (PVL) on cranial ultrasound, Cystic periventricular leukomalacia (PVL) on cranial ultrasound, 4 months or before hospital discharge, whichever occurs first|Number of participants with patent ductus arteriosus (PDA) treated medically, Patent ductus arteriosus (PDA) treated medically, 4 months or before hospital discharge, whichever occurs first|Number of participants with PDA treated with transcatheter closure or surgical ligation, PDA treated with transcatheter closure or surgical ligation, 4 months or before hospital discharge, whichever occurs first|Number of participants with necrotising enterocolitis (NEC) Bell stage 2 or greater, Necrotising enterocolitis (NEC) Bell stage 2 or greater, 4 months or before hospital discharge, whichever occurs first|Number of participants with spontaneous intestinal perforation (SIP), Spontaneous intestinal perforation (SIP), 4 months or before hospital discharge, whichever occurs first|Number of participants with retinopathy of prematurity (ROP) stage 3 or greater, Retinopathy of prematurity (ROP) stage 3 or greater, 4 months or before hospital discharge, whichever occurs first|Number of participants who die before or have BPD at 36 weeks, Death or BPD at 36 weeks, 4 months or before hospital discharge, whichever occurs first|Duration of hospitalisation (days), Duration of hospitalisation (days), 4 months or before hospital discharge, whichever occurs first|Number of participants who are discharged home in oxygen, Discharged home receiving supplemental oxygen, 4 months or before hospital discharge, whichever occurs first|Number of participants who die during first hospitalisation, Death during first hospitalisation, 4 months or before hospital discharge, whichever occurs first