Infant, Newborn, DiseasesproTeCtNCT06557551
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
A study testing Thin catheter surfactant in people with Infant, Newborn, Diseases and Prematurity, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 minutes
- Conditions the study is for
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme
- What is being tested?
- Thin catheter surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteIreland
- Study dates
- 19 Aug 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
National Maternity Hospital
Dublin, None Selected, D02 YH21
Colm PF O'Donnell, MB PhD, 35316373100, codonnell@nmh.ie
About this study
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:
Read more
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.
Read the 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 (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.
- Conditions
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
- Being tested
- Thin catheter surfactant
- Medical subject headings
- Infant, Newborn, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin catheter surfactantOther
Surfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life
| Study group | Role | What they receive |
|---|---|---|
| Thin catheter surfactant | Experimental | 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. Receives: Other: Thin catheter surfactant |
| Standard care | No intervention | Participants will continue on face mask breathing support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants intubated in the first 72 hours of life
Endotracheal intubation
- in the Delivery Room for apnoea or bradycardia despite mask PPV; or
- 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
Measured: First 72 hours of life
Secondary outcomes (26)
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)
Measured: 30 minutes
Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR)
Bradycardia (HR < 100bpm) in the DR
Measured: 30 minutes
Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR
Mask PPV in the DR
Measured: 30 minutes
Number of participants who undergo endotracheal intubation in the DR
Endotracheal intubation in the DR
Measured: 30 minutes
Number of participants who receive chest compressions in the DR
Chest compressions in the DR
Measured: 30 minutes
Number of participants who receive adrenaline in the DR
Adrenaline administration in the DR
Measured: 30 minutes
Number of participants who receive volume expansion in the DR
Volume expansion in the DR
Measured: 30 minutes
Number of participants who are itubated at any time during hospitalisation
Intubation at any time during hospitalisation
Measured: 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
Measured: 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
Measured: 4 months or before hospital discharge, whichever occurs first
Duration of mechanical ventilation (days)
Duration of mechanical ventilation (days)
Measured: 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)
Measured: 4 months or before hospital discharge, whichever occurs first
Duration of oxygen therapy (days)
Duration of oxygen therapy (days)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 months or before hospital discharge, whichever occurs first
Number of participants with spontaneous intestinal perforation (SIP)
Spontaneous intestinal perforation (SIP)
Measured: 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
Measured: 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
Measured: 4 months or before hospital discharge, whichever occurs first
Duration of hospitalisation (days)
Duration of hospitalisation (days)
Measured: 4 months or before hospital discharge, whichever occurs first
Number of participants who are discharged home in oxygen
Discharged home receiving supplemental oxygen
Measured: 4 months or before hospital discharge, whichever occurs first
Number of participants who die during first hospitalisation
Death during first hospitalisation
Measured: 4 months or before hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start19 Aug 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open-label, parallel group group study
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colm PF O'Donnell, Principal investigator, National Maternity Hospital, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557551
- Sponsor's protocol ID
- proTeCt 01
- Acronym
- proTeCt
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data may be made available to other researchers on receipt of acceptable written request by principal Investigator
Publications
Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.
PubMed 33970483Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.
PubMed 38709215Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.
PubMed 23152207
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
- ClinicalTrials.gov ID
- NCT06557551
- Acronym / sponsor ID
- proTeCt / proTeCt 01
- Conditions
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, open-label, parallel group group study
| Arm | Type | Receives |
|---|---|---|
| Thin catheter surfactant | Experimental | Other: Thin catheter surfactantAt 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. |
| Standard care | No intervention | –Participants will continue on face mask breathing support. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thin catheter surfactantSurfactant given through thin catheter inserted under video laryngoscopy at or after 5 minutes of life | Other | Thin catheter surfactant |
Primary outcome
Number of participants intubated in the first 72 hours of life
Time frame: 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
26 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)
Time frame: 30 minutes
Number of participants with bradycardia [heart rate (HR) < 100bpm] in the Delivery Room (DR)
Time frame: 30 minutes
Number of participants who receive mask Positive Pressure Ventilation (PPV) in the DR
Time frame: 30 minutes
Number of participants who undergo endotracheal intubation in the DR
Time frame: 30 minutes
Number of participants who receive chest compressions in the DR
Time frame: 30 minutes
Number of participants who receive adrenaline in the DR
Time frame: 30 minutes
Number of participants who receive volume expansion in the DR
Time frame: 30 minutes
Number of participants who are itubated 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
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
Time frame: 4 months or before hospital discharge, whichever occurs first
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)
Time frame: 4 months or before hospital discharge, whichever occurs first
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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who receive postnatal steroids for BPD
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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants with 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants with 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants with 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
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who die before or have BPD at 36 weeks
Time frame: 4 months or before hospital discharge, whichever occurs first
Duration of hospitalisation (days)
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who are discharged home in oxygen
Time frame: 4 months or before hospital discharge, whichever occurs first
Number of participants who die during first hospitalisation
Time frame: 4 months or before hospital discharge, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 33970483Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.
- Background: PubMed 38709215Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.
- Background: PubMed 23152207Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD001456. doi: 10.1002/14651858.CD001456.pub2.
- Individual participant dataSharing planned: Yes. Participant data may be made available to other researchers on receipt of acceptable written request by principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colm PF O'Donnell principal investigator
National Maternity Hospital, University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thin catheter surfactant in people with Infant, Newborn, Diseases and Prematurity, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colm PF O'Donnell, MB PhD (35316373100, codonnell@nmh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants intubated in the first 72 hours of life (time frame: First 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.