Newborn MorbidityINTEXUSNCT04070066
Educational Strategy in Exchange Transfusion
A study testing Digital didactic environment and • Simulated scenario in people with Newborn Morbidity and Simulation Training, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
Abstract Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Newborn Morbidity, Simulation Training, Telemedicine
- What is being tested?
- Digital didactic environment and • Simulated scenario
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 30 Aug 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- o Men and women of legal age who are students enrolled in a paediatrics specialization programme at Colombian university medical schools.
- Students in any year of specialization in paediatrics.
Who cannot join
- Students who are, as part of their curriculum, in a rotation outside the country.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Strategy for the Development of Skills in Exchange Trnasfusion: a Randomized Clinical Trial Protocol
Abstract
Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way.
Read more
Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used.
Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.
- Conditions
- Newborn Morbidity, Simulation Training, Telemedicine, Assessment, Self
- Being tested
- Digital didactic environment, • Simulated scenario
- Keywords
- Newborn, infant, exchange-transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital didactic environmentOther
Students assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies.
• Simulated scenarioOther
The educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios.
| Study group | Role | What they receive |
|---|---|---|
| Digital didactic environment | Experimental | Students assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies. Receives: Other: Digital didactic environment |
| • Simulated scenario | Active comparator | The educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios. Receives: Other: • Simulated scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall result of the OSCE evaluation (checklist).
The performance score will be the score obtained for the evaluation divided by the maximum possible score of the test and multiplied by 100. A superior performance is defined as a score greater than or equal to 85%, and a nonsuperior performance is defined as a score equal to or less than 84%.
Measured: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Secondary outcomes (3)
Performance on the OSCE checklist in sub-areas: Clinical History
Clinical history and approach to patient risk and indication for exchange transfusion
Measured: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Performance on the OSCE checklist in sub-areas: assesment
Comprehensive assessment of the patient with neonatal jaundice
Measured: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Performance on the OSCE checklist in sub-areas: exchange transfusion
Management of the patient with neonatal jaundice and indication for exchange transfusion
Measured: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start30 Aug 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn MorbidityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the assignment of the students to the study groups, a randomization sequence will be generated through a computer-generated process. This process will be centralized in the paediatric office of the Universidad de La Sabana (University of La Sabana). The sequence will be generated through the Research Randomizer page (www.randomizer.org), and a permuted blocks strategy with block size of eight (8) will be used. The permuted blocks strategy and the size of the blocks will not be known by the researcher. To ensure the concealment of the random sequence, it will be placed in opaque envelopes at the time of assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sergio Ivan agudelo Perez, Universidad de la Sabana
- Investigators
- Maria J Maldonado, Pediatrician, Principal investigator, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070066
- Sponsor's protocol ID
- 451
- Acronym
- INTEXUS
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2019
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Maldonado MJ, Agudelo SI, Suarez JD, Gamboa O. Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol. Trials. 2020 May 7;21(1):387. doi: 10.1186/s13063-020-04312-3.
PubMed 32381105
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Strategy for the Development of Skills in Exchange Trnasfusion: a Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT04070066
- Acronym / sponsor ID
- INTEXUS / 451
- Conditions
- Newborn Morbidity, Simulation Training, Telemedicine, Assessment, Self
- Keywords
- Newborn, infant, exchange-transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 28 Aug 2019 (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.
Abstract
Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way.
Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used.
Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For the assignment of the students to the study groups, a randomization sequence will be generated through a computer-generated process. This process will be centralized in the paediatric office of the Universidad de La Sabana (University of La Sabana). The sequence will be generated through the Research Randomizer page (www.randomizer.org), and a permuted blocks strategy with block size of eight (8) will be used. The permuted blocks strategy and the size of the blocks will not be known by the researcher. To ensure the concealment of the random sequence, it will be placed in opaque envelopes at the time of assignment.
| Arm | Type | Receives |
|---|---|---|
| Digital didactic environment | Experimental | Other: Digital didactic environmentStudents assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies. |
| • Simulated scenario | Active comparator | Other: • Simulated scenarioThe educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- o Men and women of legal age who are students enrolled in a paediatrics specialization programme at Colombian university medical schools.
Key exclusion criteria (1 listed)
- Students who are, as part of their curriculum, in a rotation outside the country.
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 |
|---|---|---|
| Digital didactic environmentStudents assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies. | Other | Digital didactic environment |
| • Simulated scenarioThe educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios. | Other | • Simulated scenario |
Primary outcome
Overall result of the OSCE evaluation (checklist).
Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
The performance score will be the score obtained for the evaluation divided by the maximum possible score of the test and multiplied by 100. A superior performance is defined as a score greater than or equal to 85%, and a nonsuperior performance is defined as a score equal to or less than 84%.
3 secondary outcomes
Performance on the OSCE checklist in sub-areas: Clinical History
Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Performance on the OSCE checklist in sub-areas: assesment
Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Performance on the OSCE checklist in sub-areas: exchange transfusion
Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 32381105Maldonado MJ, Agudelo SI, Suarez JD, Gamboa O. Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol. Trials. 2020 May 7;21(1):387. doi: 10.1186/s13063-020-04312-3.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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. This study is not recruiting at the moment.
Maria J Maldonado, Pediatrician principal investigator
Universidad de la Sabana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital didactic environment and • Simulated scenario in people with Newborn Morbidity and Simulation Training, run by Universidad de la Sabana at 1 site in Colombia.
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 2 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: finished, as of the sponsor's last update on 20 Jan 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall result of the OSCE evaluation (checklist). (time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios). 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 NCT04070066, which also lists 1 linked publication.
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 20 Jan 2025.