An interventional study of Thin catheter surfactant in Infant, Newborn, Diseases, Prematurity and Prematurity; Extreme, sponsored by University College Dublin. Recruiting at 1 site in Ireland. Open to participants aged Up to 30 Minutes. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University College Dublin · Not applicable, Interventional, and Treatment
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:
All babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.
Preterm infants - particularly those born before 28 weeks of gestation - are at risk of developing respiratory distress syndrome (RDS), a condition characterised by structural and functional lung immaturity that leads to progressive respiratory failure. Infants at high risk of or who show early signs of RDS are treated with continuous positive airway pressure (CPAP) in an attempt to prevent respiratory failure. Infants whose RDS worsens despite CPAP are given surfactant. To give surfactant, clinicians use a laryngoscope to view the airway and insert a relatively wide-bore endotracheal tube (ETT) directly into the trachea. When an ETT is used to deliver surfactant, the ETT usually remains in place for a period of mechanical ventilation (MV). Clinicians aim to minimise the duration of ventilation, as even short periods of MV may be harmful to the preterm lung. An alternative approach, sometimes called "less-invasive surfactant application" (LISA), is to give surfactant through a thin endotracheal catheter. These thin catheters (TC) cannot be used for mechanical ventilation and so they are immediately removed after the surfactant has been given.
A Cochrane systematic review found that, compared to giving surfactant through an ETT in the NICU, TC surfactant is associated with reduced risk of death or bronchopulmonary dysplasia (BPD), less intubation in the first 72 hours and reduced incidence of major complications and in-hospital mortality. However, the studies included in the systematic review are heterogenous, few of them enrolled infants born before 28 weeks of gestation and none of them evaluated the effects of giving TC surfactant shortly after birth, before starting CPAP in the NICU. In all of these studies, the clinician inserting the TC viewed the airway directly through the mouth (i.e. performed direct laryngoscopy).
Inserting an ETT in a newborn infant using direct laryngoscopy is challenging. Clinicians use clinical signs detected during positive pressure ventilation (PPV) (e.g. detection of exhaled carbon dioxide, auscultation of breath sounds, condensation in the tube in expiration) to determine whether the ETT has been placed correctly. We recently demonstrated that more first intubation attempts with an ETT in newborn infants are successful when clinicians used a video laryngoscope (VL) to view the airway indirectly compared to direct laryngoscopy. . As PPV cannot be given through a TC, the only way of determining the position of a TC is to see it enter the larynx. Using VL during TC insert attempts allows multiple observers to simultaneously and independently determine whether it is in the correct place.
The earlier that surfactant is given, the more effective it appears to be. It is possible that TC surfactant given "prophylactically" - i.e. very shortly after birth, when there are minimal signs of respiratory distress - under VL guidance may substantially reduce the rate of intubation for respiratory failure. If it does, that holds out the prospect that it may reduce rates of the adverse outcomes associated with ventilation (death or BPD etc.) in preterm infants.
139 studies on the registry are indexed under Infant, Newborn, Diseases; 31 are open to participants now.
This study's planned enrollment of 164 is above the median of 80 across 83 interventional studies indexed under Infant, Newborn, Diseases.
Browse Infant, Newborn, Diseases studies →University College Dublin is the lead sponsor of 113 studies on the registry; 32 are open to participants now.
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Exclusion criteria
At or after 5 minutes of life, participants will have a thin endotracheal catheter (Surfcath, Vygon, Ecouen, France) inserted under video laryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany), through which they will receive surfactant (Curosurf, Chiesi Farmaceutici, Parma, Italy - 120mg for infants \< 26 weeks, 240mg for infants 26 - 27+6 weeks). The catheter will then be removed, and they will continue on face mask breathing support.
Other: Thin catheter surfactant
Participants will continue on face mask breathing support.
Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life
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
Time frame: First 72 hours of life
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)
Time frame: 30 minutes
Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR)
Bradycardia (HR \< 100bpm) in the DR
Time frame: 30 minutes
Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR
Mask PPV in the DR
Time frame: 30 minutes
Number of participants who undergo endotracheal intubation in the DR
Endotracheal intubation in the DR
Time frame: 30 minutes
Number of participants who receive chest compressions in the DR
Chest compressions in the DR
Time frame: 30 minutes
Number of participants who receive adrenaline in the DR
Adrenaline administration in the DR
Time frame: 30 minutes
Number of participants who receive volume expansion in the DR
Volume expansion in the DR
Time frame: 30 minutes
Number of participants who are itubated at any time during hospitalisation
Intubation at any time during hospitalisation
Time frame: 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
Time frame: 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Duration of mechanical ventilation (days)
Duration of mechanical ventilation (days)
Time frame: 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)
Time frame: 4 months or before hospital discharge, whichever occurs first
Duration of oxygen therapy (days)
Duration of oxygen therapy (days)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants with spontaneous intestinal perforation (SIP)
Spontaneous intestinal perforation (SIP)
Time frame: 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
Time frame: 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Duration of hospitalisation (days)
Duration of hospitalisation (days)
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who are discharged home in oxygen
Discharged home receiving supplemental oxygen
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who die during first hospitalisation
Death during first hospitalisation
Time frame: 4 months or before hospital discharge, whichever occurs first
Plan to share: Yes — Participant data may be made available to other researchers on receipt of acceptable written request by principal Investigator
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Available 1 year after publication for 2 years
Access criteria: Participant data may be made available to other researchers on receipt of acceptable written request by principal Investigator
Started Aug 2024 (actual). Primary completion is estimated for Nov 2026, 27 months after the start.
Of 42 non-industry interventional studies with no phase under Infant, Newborn, Diseases, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 34. This study's planned 27 months is above that.
Counting every sponsor, half of 44 studies reached it within 19 months; a quarter within 11 and three quarters within 37.
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