Respiratory Distress Syndrome, NewbornNINJANCT06898801
An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.
A study testing Just-in-time video training in people with Respiratory Distress Syndrome, Newborn and Endotracheal Intubation, run by University College Dublin at 1 site in Ireland.
Trial summary
This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Endotracheal Intubation, Neonatal Intubation Performance
- What is being tested?
- Just-in-time video training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2025to May 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.
Who cannot join
- Neonates with an upper airway malformation.
- If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna E Curley contact
Ireland1 site
Department of Neonatology, The National Maternity Hospital
Dublin, D02 YH21
About this study
Official title: Neonatal INtubation After "Just-in-time" Audiovisual Training: a Randomised Controlled Trial
This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.
The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.
Read more
In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.
The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.
Read the detailed description
Performing an urgent intubation on a critically ill newborn can be stressful and daunting. It is a vital, life-saving skill for not only neonatologists but paediatricians who may be faced with the rare scenario of an unwell newborn in respiratory distress. Neonatal intubation remains a mandatory competency of the higher speciality training scheme in General Paediatrics ( Royal College of Physicians of Ireland.) This is in line with paediatric training in the UK and Europe and neonatal intubation competency remains a concern not only in Ireland but worldwide. Teaching neonatal intubation via an apprenticeship model needs to be balanced with the need to minimise risk to babies of prolonged or repeated attempts. Paediatric and neonatal trainees can struggle to achieve competency in this skill as advances in perinatal care such as non-invasive ventilation, less invasive surfactant methods and avoidance of universal intubation for meconium have decreased the number of routine intubations performed. With greater numbers of doctors and advanced neonatal nurse practitioners and fewer working hours, the number of intubation opportunities for trainees continues to fall. Even for more experienced practitioners it can be challenging to maintain intubation competency.
The teaching of skills to paediatricians and neonatologists needs to adapt to the changing nature of training. "Just-in-Time" (JiT) educational interventions have been studied in a variety of simulated and clinical environments to improve training or increase success of uncommonly performed procedures by providing a brief educational intervention shortly before performing the procedure . A study by Gizicki et al applied this concept to neonatal intubation in the clinical setting. They randomised 65 residents performing intubation to receive a Just-in-Time manikin based low fidelity simulation session or a 5-minute video just before performing an intubation. They did not demonstrate a difference in overall intubation success rates between these groups although intubation success rates in both groups were higher than baseline. Intubation in this study was performed using both direct and video laryngoscopy. It has been demonstrated that video laryngoscopy (VL) improves neonatal intubation success, but the method of intubation differs from standard laryngoscopy and there is a learning curve for operators using this device initially. Given that video laryngoscopic intubation is likely to become the standard of care, there is a need to train operators to use this device correctly in order to benefit from its greater utility.
A recent study performed in the National Maternity Hospital by Ni Chathasaigh et al examined video recordings of neonatal intubations using VL. The VAN (Video laryngoscopic Analysis of Neonatal Intubations) study recorded the external environment in addition to the internal VL views of the baby's airway. Analysis of these videos highlights common features of successful and unsuccessful attempts. Using the lessons from the VAN study, the investigators propose a study of a novel "Just-in-Time" educational video to improve intubation performance by reducing the total time required from insertion of the laryngoscope to successful intubation. The "Just-in-Time" video will supplement an intubation checklist and will concentrate on the key aspects of intubation; anatomy, intubator position, cricoid pressure, laryngoscopic technique and supervisor instructions. The "Just-in-Time" video will be directed at the intubator, supervisor and assisting nurse.
- Conditions
- Respiratory Distress Syndrome, Newborn, Endotracheal Intubation, Neonatal Intubation Performance, Prematurity, Neonate, Education, Medical
- Being tested
- Just-in-time video training
- Keywords
- Just-in-Time, Neonatal intubation, Teaching
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-in-time video trainingOther
A "Just-in-time" educational video was designed and produced by the investigating team. Content of the video includes;
- Environmental set up and patient positioning
- Equipment preparation including stylet insertion
- Description of internal anatomy of airway
- Suggested instructional language for supervisors
- Example footage of an intubation
- Tips and common pitfalls
- Guidance for intubation assistant on how to perform "cricoid" pressure
| Study group | Role | What they receive |
|---|---|---|
| Just-in-Time Intervention | Experimental | The primary intubator, supervising clinician and intubation assistant or nurse will view the brief "Just-in-time" video once, immediately prior to performing the intubation with a video laryngoscope. The decision to intubate an infant and who will perform the intubation will be made by the clinical team. Other aspects of the procedure, for example premedications, use of pre-intubation checklist will not change from standard practice. Receives: Other: Just-in-time video training |
| Control | No intervention | Intubation will be carried out as per current standard practice with supervision of trainee by senior clinician or initial intubation by senior clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total laryngoscopy time in seconds
An intubation attempt is defined as the introduction of the laryngoscope blade into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted. Laryngoscopy time is the time from insertion of the laryngoscope blade into the mouth during an intubation attempt until removal of the blade, regardless of whether an ETT was successfully inserted. Total laryngoscopy time is defined as the cumulative duration of laryngoscopy time of all intubation attempts undertaken until ETT is inserted and confirmed by exhaled carbon dioxide detection or the procedure is abandoned.
Measured: 24 months
Secondary outcomes (8)
Number of intubation attempts
The number of times the laryngoscope blade is inserted into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted in one encounter until correct placement of ETT tube, confirmed by exhaled carbon dioxide detection, or procedure abandoned
Measured: 24 months
Duration of each attempt
Duration in seconds of each intubation attempt in an encounter defined as insertion of laryngoscope into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted.
Measured: 24 months
Lowest heart rate during attempt
Lowest heart rate measured on bedside monitor during intubation attempt (defined above)
Measured: 24 months
Lowest oxygen saturation during attempt
Lowest oxygen saturation measured measured on bedside monitor during intubation attempt (defined above)
Measured: 24 months
Chest compressions during procedure
If chest compressions are required during the intubation
Measured: 24 months
Adrenaline administration during procedure
If bolus adrenaline administration is required during intubation procedure
Measured: 24 months
Oral trauma
If oral trauma is sustained during an intubation
Measured: 24 months
Crossover to alternative operator
Where there are multiple intubation attempts in an encounter, if the practitioner performing intubation is substituted for another for one or more of the attempts
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Shortly before an intubation, a neonate for intubation will be randomised in 1:1 ratio to "Just-in-Time" intervention or none. Randomisation will be stratified by gestational age category: \<32 week gestational age (GA) or \>32 weeks GA. Allocations will be in sealed opaque envelopes in random order according to gestational age strata. Allocation envelopes will be stored in a dedicated box in the Neonatal Intensive Care Unit (NICU). One randomisation will be carried out for each intubation encounter regardless of number of attempts. Each baby will only be included in the study once. The intubator and team will not be blinded to group assignment as masking will not be possible. Investigators will not be blinded. Outcome assessors will be blinded to the randomisation group.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- National Maternity Hospital, Ireland
- Responsible party
- Sponsor
- Investigators
- Anna E Curley, Principal investigator, Department of Neonatology, National Maternity Hospital. University College DublinEoin O'Currain, Principal investigator, Department of Neonatology, National Maternity Hospital. University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898801
- Sponsor's protocol ID
- EC44.2024
- Acronym
- NINJA
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
O'Keeffe AG, Ambler G, Barber JA. Sample size calculations based on a difference in medians for positively skewed outcomes in health care studies. BMC Med Res Methodol. 2017 Dec 2;17(1):157. doi: 10.1186/s12874-017-0426-1.
PubMed 29197347Kothari R, Hodgson KA, Davis PG, Thio M, Manley BJ, O'Currain E. Time to desaturation in preterm infants undergoing endotracheal intubation. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):603-607. doi: 10.1136/archdischild-2020-319509. Epub 2021 Apr 30.
PubMed 33931396Foran J, Moore CM, Ni Chathasaigh CM, Moore S, Purna JR, Curley A. Nasal high-flow therapy to Optimise Stability during Intubation: the NOSI pilot trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):244-249. doi: 10.1136/archdischild-2022-324649. Epub 2022 Oct 28.
PubMed 36307187Ni Chathasaigh CM, Dunne EA, Geraghty LE, O'Donnell CPF, O'Currain E, Curley AE. Video analysis of neonatal intubations using video laryngoscopy: a prospective comparison of clinical practice with resuscitation guidelines. Arch Dis Child Fetal Neonatal Ed. 2025 Aug 19;110(5):479-484. doi: 10.1136/archdischild-2024-327723.
PubMed 39832821O'Shea JE, Loganathan P, Thio M, Kamlin COF, Davis PG. Analysis of unsuccessful intubations in neonates using videolaryngoscopy recordings. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F408-F412. doi: 10.1136/archdischild-2017-313628. Epub 2017 Nov 10.
PubMed 29127153Corder W, Nelin T, Ades AM, Flibotte J, Laverriere E, Daly Guris R, Soorikian L, Foglia EE. Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2024 Dec 20;110(1):91-95. doi: 10.1136/archdischild-2024-326992.
PubMed 38951016Ni Chathasaigh CM, O'Currain E, Curley AE. Variations in newborn airway management. Ir Med J. 2023 May 18;116(5):776. No abstract available.
PubMed 37555533Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
PubMed 37171122Riva T, Engelhardt T, Basciani R, Bonfiglio R, Cools E, Fuchs A, Garcia-Marcinkiewicz AG, Greif R, Habre W, Huber M, Petre MA, von Ungern-Sternberg BS, Sommerfield D, Theiler L, Disma N; OPTIMISE Collaboration. Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2023 Feb;7(2):101-111. doi: 10.1016/S2352-4642(22)00313-3. Epub 2022 Nov 24.
PubMed 36436541Geraghty 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 38709215Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.
PubMed 37353151McKay J, Wasserman M, Monuteaux MC, Hirsch AW, Nagler J. Just-in-time procedural training for pediatric emergency medicine trainees: A randomized educational interventional trial. AEM Educ Train. 2023 Jun 22;7(3):e10886. doi: 10.1002/aet2.10886. eCollection 2023 Jun.
PubMed 37361189Braga MS, Tyler MD, Rhoads JM, Cacchio MP, Auerbach M, Nishisaki A, Larson RJ. Effect of just-in-time simulation training on provider performance and patient outcomes for clinical procedures: a systematic review. BMJ Simul Technol Enhanc Learn. 2015 Oct 5;1(3):94-102. doi: 10.1136/bmjstel-2015-000058. eCollection 2015.
PubMed 35515199O'Shea JE, Scrivens A, Edwards G, Roehr CC. Safe emergency neonatal airway management: current challenges and potential approaches. Arch Dis Child Fetal Neonatal Ed. 2022 May;107(3):236-241. doi: 10.1136/archdischild-2020-319398. Epub 2021 Apr 21.
PubMed 33883207
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal INtubation After "Just-in-time" Audiovisual Training: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06898801
- Acronym / sponsor ID
- NINJA / EC44.2024
- Conditions
- Respiratory Distress Syndrome, Newborn, Endotracheal Intubation, Neonatal Intubation Performance, Prematurity, Neonate, Education, Medical
- Keywords
- Just-in-Time, Neonatal intubation, Teaching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- National Maternity Hospital, Ireland
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2025 (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.
This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.
The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.
In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.
The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.
Detailed description
Performing an urgent intubation on a critically ill newborn can be stressful and daunting. It is a vital, life-saving skill for not only neonatologists but paediatricians who may be faced with the rare scenario of an unwell newborn in respiratory distress. Neonatal intubation remains a mandatory competency of the higher speciality training scheme in General Paediatrics ( Royal College of Physicians of Ireland.) This is in line with paediatric training in the UK and Europe and neonatal intubation competency remains a concern not only in Ireland but worldwide. Teaching neonatal intubation via an apprenticeship model needs to be balanced with the need to minimise risk to babies of prolonged or repeated attempts. Paediatric and neonatal trainees can struggle to achieve competency in this skill as advances in perinatal care such as non-invasive ventilation, less invasive surfactant methods and avoidance of universal intubation for meconium have decreased the number of routine intubations performed. With greater numbers of doctors and advanced neonatal nurse practitioners and fewer working hours, the number of intubation opportunities for trainees continues to fall. Even for more experienced practitioners it can be challenging to maintain intubation competency.
The teaching of skills to paediatricians and neonatologists needs to adapt to the changing nature of training. "Just-in-Time" (JiT) educational interventions have been studied in a variety of simulated and clinical environments to improve training or increase success of uncommonly performed procedures by providing a brief educational intervention shortly before performing the procedure . A study by Gizicki et al applied this concept to neonatal intubation in the clinical setting. They randomised 65 residents performing intubation to receive a Just-in-Time manikin based low fidelity simulation session or a 5-minute video just before performing an intubation. They did not demonstrate a difference in overall intubation success rates between these groups although intubation success rates in both groups were higher than baseline. Intubation in this study was performed using both direct and video laryngoscopy. It has been demonstrated that video laryngoscopy (VL) improves neonatal intubation success, but the method of intubation differs from standard laryngoscopy and there is a learning curve for operators using this device initially. Given that video laryngoscopic intubation is likely to become the standard of care, there is a need to train operators to use this device correctly in order to benefit from its greater utility.
A recent study performed in the National Maternity Hospital by Ni Chathasaigh et al examined video recordings of neonatal intubations using VL. The VAN (Video laryngoscopic Analysis of Neonatal Intubations) study recorded the external environment in addition to the internal VL views of the baby's airway. Analysis of these videos highlights common features of successful and unsuccessful attempts. Using the lessons from the VAN study, the investigators propose a study of a novel "Just-in-Time" educational video to improve intubation performance by reducing the total time required from insertion of the laryngoscope to successful intubation. The "Just-in-Time" video will supplement an intubation checklist and will concentrate on the key aspects of intubation; anatomy, intubator position, cricoid pressure, laryngoscopic technique and supervisor instructions. The "Just-in-Time" video will be directed at the intubator, supervisor and assisting nurse.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Shortly before an intubation, a neonate for intubation will be randomised in 1:1 ratio to "Just-in-Time" intervention or none. Randomisation will be stratified by gestational age category: <32 week gestational age (GA) or >32 weeks GA. Allocations will be in sealed opaque envelopes in random order according to gestational age strata. Allocation envelopes will be stored in a dedicated box in the Neonatal Intensive Care Unit (NICU). One randomisation will be carried out for each intubation encounter regardless of number of attempts. Each baby will only be included in the study once. The intubator and team will not be blinded to group assignment as masking will not be possible. Investigators will not be blinded. Outcome assessors will be blinded to the randomisation group.
| Arm | Type | Receives |
|---|---|---|
| Just-in-Time Intervention | Experimental | Other: Just-in-time video trainingThe primary intubator, supervising clinician and intubation assistant or nurse will view the brief "Just-in-time" video once, immediately prior to performing the intubation with a video laryngoscope. The decision to intubate an infant and who will perform the intubation will be made by the clinical team. Other aspects of the procedure, for example premedications, use of pre-intubation checklist will not change from standard practice. |
| Control | No intervention | –Intubation will be carried out as per current standard practice with supervision of trainee by senior clinician or initial intubation by senior clinician. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.
Key exclusion criteria (2 listed)
- Neonates with an upper airway malformation.
- If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest
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 |
|---|---|---|
| Just-in-time video trainingA "Just-in-time" educational video was designed and produced by the investigating team. Content of the video includes; * Environmental set up and patient positioning * Equipment preparation including stylet insertion * Description of internal anatomy of airway * Suggested instructional language for supervisors * Example footage of an intubation * Tips and common pitfalls * Guidance for intubation assistant on how to perform "cricoid" pressure | Other | Just-in-Time Intervention |
Primary outcome
Total laryngoscopy time in seconds
Time frame: 24 months
An intubation attempt is defined as the introduction of the laryngoscope blade into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted. Laryngoscopy time is the time from insertion of the laryngoscope blade into the mouth during an intubation attempt until removal of the blade, regardless of whether an ETT was successfully inserted. Total laryngoscopy time is defined as the cumulative duration of laryngoscopy time of all intubation attempts undertaken until ETT is inserted and confirmed by exhaled carbon dioxide detection or the procedure is abandoned.
8 secondary outcomes
Number of intubation attempts
Time frame: 24 months
Duration of each attempt
Time frame: 24 months
Lowest heart rate during attempt
Time frame: 24 months
Lowest oxygen saturation during attempt
Time frame: 24 months
Chest compressions during procedure
Time frame: 24 months
Adrenaline administration during procedure
Time frame: 24 months
Oral trauma
Time frame: 24 months
Crossover to alternative operator
Time frame: 24 months
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 27 Mar 2025.
- Background: PubMed 29197347O'Keeffe AG, Ambler G, Barber JA. Sample size calculations based on a difference in medians for positively skewed outcomes in health care studies. BMC Med Res Methodol. 2017 Dec 2;17(1):157. doi: 10.1186/s12874-017-0426-1.
- Background: PubMed 33931396Kothari R, Hodgson KA, Davis PG, Thio M, Manley BJ, O'Currain E. Time to desaturation in preterm infants undergoing endotracheal intubation. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):603-607. doi: 10.1136/archdischild-2020-319509. Epub 2021 Apr 30.
- Background: PubMed 36307187Foran J, Moore CM, Ni Chathasaigh CM, Moore S, Purna JR, Curley A. Nasal high-flow therapy to Optimise Stability during Intubation: the NOSI pilot trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):244-249. doi: 10.1136/archdischild-2022-324649. Epub 2022 Oct 28.
- Background: PubMed 39832821Ni Chathasaigh CM, Dunne EA, Geraghty LE, O'Donnell CPF, O'Currain E, Curley AE. Video analysis of neonatal intubations using video laryngoscopy: a prospective comparison of clinical practice with resuscitation guidelines. Arch Dis Child Fetal Neonatal Ed. 2025 Aug 19;110(5):479-484. doi: 10.1136/archdischild-2024-327723.
- Background: PubMed 29127153O'Shea JE, Loganathan P, Thio M, Kamlin COF, Davis PG. Analysis of unsuccessful intubations in neonates using videolaryngoscopy recordings. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F408-F412. doi: 10.1136/archdischild-2017-313628. Epub 2017 Nov 10.
- Background: PubMed 38951016Corder W, Nelin T, Ades AM, Flibotte J, Laverriere E, Daly Guris R, Soorikian L, Foglia EE. Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2024 Dec 20;110(1):91-95. doi: 10.1136/archdischild-2024-326992.
- Background: PubMed 37555533Ni Chathasaigh CM, O'Currain E, Curley AE. Variations in newborn airway management. Ir Med J. 2023 May 18;116(5):776. No abstract available.
- Background: PubMed 37171122Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
- Background: PubMed 36436541Riva T, Engelhardt T, Basciani R, Bonfiglio R, Cools E, Fuchs A, Garcia-Marcinkiewicz AG, Greif R, Habre W, Huber M, Petre MA, von Ungern-Sternberg BS, Sommerfield D, Theiler L, Disma N; OPTIMISE Collaboration. Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2023 Feb;7(2):101-111. doi: 10.1016/S2352-4642(22)00313-3. Epub 2022 Nov 24.
- 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 37353151Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.
- Background: PubMed 37361189McKay J, Wasserman M, Monuteaux MC, Hirsch AW, Nagler J. Just-in-time procedural training for pediatric emergency medicine trainees: A randomized educational interventional trial. AEM Educ Train. 2023 Jun 22;7(3):e10886. doi: 10.1002/aet2.10886. eCollection 2023 Jun.
- Individual participant dataSharing planned: Undecided
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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.
Anna E Curley contact
Anna E Curley principal investigator
Department of Neonatology, National Maternity Hospital. University College Dublin
Eoin O'Currain principal investigator
Department of Neonatology, 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 Just-in-time video training in people with Respiratory Distress Syndrome, Newborn and Endotracheal Intubation, 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Mar 2025. 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 Elizabeth H Murphy (+353862168183, elizabeth.murphy2@nmh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total laryngoscopy time in seconds (time frame: 24 months). 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 NCT06898801, which also lists 14 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 27 Mar 2025.