Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557551
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth the ProTeCt Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth the ProTeCt Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
proTeCt
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
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
Detailed Description:
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 ie 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 eg 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 - ie 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
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 ie 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 eg 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 - ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None