Respiration; Insufficient or Poor, NewbornCORSADNCT02563717
Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age
A study testing T-piece used for respiratory support (several manufacturers) and New system used for respiratory support in people with Respiration; Insufficient or Poor, Newborn and Infant, Premature, Diseases, run by Baldvin Jonsson at 6 sites in 5 countries.
Trial summary
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)? Trial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiration; Insufficient or Poor, Newborn, Infant, Premature, Diseases
- What is being tested?
- T-piece used for respiratory support (several manufacturers) and New system used for respiratory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Mar 2016to 18 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Born <28 weeks gestational age at a university hospital
- Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given
Who cannot join
- Decision on treatment limitations before randomisation
- Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
- Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
- Known neuromuscular disease
- No study neonatologist available
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Sweden2 sites
University Hospital Linköping, Department of Pediatrics
Linköping, 58185
Karolinska University Hospital, Neonatology department
Stockholm, 171 76
Iceland1 site
Department of neonatology, University Hospital of Iceland
Reykjavik, 101
Lithuania1 site
Neonatal Unit, Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406
Norway1 site
Stavanger University Hospital, Department of Pediatrics
Stavanger, 4011
Poland1 site
Department of Neonatology, Poznan University of Medical Sciences
Poznan, 60-535
About this study
Official title: A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?
Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born <28 weeks.
Read the detailed description
The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.
The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.
During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.
Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.
After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.
The management of respiratory support is according to international guidelines and a detailed description is provided in the clinical management appendix. The intervention is respiratory support for the first 10-30 minutes of life and will begin after birth when the infant is transferred to the resuscitation team. The intervention ends 1) when an infant is intubated (primary outcome), 2) after a minimum of 10 minutes support, with the randomized system, the patient is stable and breathing adequately, 3) at 30 minutes when the respiratory support can continue as decided by the clinicians (cross-over not allowed).
Apart from the system used for respiratory support all patients will receive standard care. No assessments or investigations of the trial subjects are planned. Data will be reported by the resuscitation team and collected from records.
The primary outcome is delivery room intubation or death. The secondary outcomes include time to intubation, use of surfactant, use of positive pressure ventilation, respiratory support at 72 hours and temperature on intensive care admission. Safety variables include pneumothorax, intraventricular haemorrhage and problems with ventilation and equipment.
All analysis will be on intention to treat and p<0.05 considered statistically significant. The primary outcome variable (delivery room intubation or death) will represent a 2x2 cross table and analysed with Pearson chi-square test. The secondary outcomes include Kaplan Meier analysis of time to intubation and comparisons of means for continuous variables. There are no predetermined subgroups. Subgroup analysis will be used to describe the population and to generate hypotheses.
- Being tested
- T-piece used for respiratory support (several manufacturers), New system used for respiratory support
- Keywords
- Resuscitation, Positive-Pressure Respiration, Infant, Extremely Premature, Continuous Positive Airway Pressure, Intubation
- Medical subject headings
- Respiratory Aspiration, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-piece used for respiratory support (several manufacturers)Device
Also called Neopuff™ Infant T-Piece Resuscitator, T-piece Disposable Circuit Kit (GE Healthcare), Other T-piece manufacturers
Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
New system used for respiratory supportDevice
Also called Manufacturing and CE-marking by Inspiration Healthcare, UK
Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
| Study group | Role | What they receive |
|---|---|---|
| Reference Device: T-piece System | Active comparator | Not described Receives: Device: T-piece used for respiratory support (several manufacturers) |
| Investigational Device: The New System | Active comparator | Not described Receives: Device: New system used for respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery room intubation or death
The primary outcome is delivery room intubation or death. Death has to be included in the primary outcome since patients that die may not always be intubated. The variable is a dichotomous outcome and reported by the resuscitation team.
Measured: 0-30 minutes
Secondary outcomes (6)
Time to primary outcome (intubation or death)
The time (minutes:hours) that a patient reach primary outcome. Data reported by resuscitation team or collected at patient record review of the first three days of life. This is a safety endpoint.
Measured: up to 72 hours of age
Death
The time (minutes:hours) that a patient died. Data reported by resuscitation team or collected at patient record review of the first three days of life. This is a safety endpoint.
Measured: up to 72 hours of age
Intra ventricular haemorrhage grade III or more
The number of patients with an intra ventricular hemorrhage grade III or more. Data collected at patient record review of the first three days of life. This is a safety endpoint.
Measured: up to 72 hours of age
Airleaks and pneumothorax
The number of patients with airleaks or pneumothorax during resuscitation or the first 72 hours of life. Data reported by resuscitation team or collected at patient record review of the first three days of life. This is a safety endpoint.
Measured: up to 72 hours of age
Failed ventilation
The number of patients with failed ventilation during resuscitation. Data reported by resuscitation team. This is a safety endpoint.
Measured: 0-30 minutes
Device problems or malfunction
The instances that there was a problem with the randomized intervention. Data reported by resuscitation team. This is a safety endpoint. Device problems or malfunction activates the adverse events handling protocol.
Measured: 0-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion15 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiration; Insufficient or Poor, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baldvin Jonsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baldvin Jonsson, Karolinska Institutet
- Investigators
- Baldvin Jonsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563717
- Sponsor's protocol ID
- 2015/927-31/4
- Acronym
- CORSAD
- Status last verified
- May 2020
- First submitted
- 24 Sep 2015
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data will be shared but method of sharing not decided
Publications
Donaldsson S, Palleri E, Jonsson B, Drevhammar T. Transition of Extremely Preterm Infants from Birth to Stable Breathing: A Secondary Analysis of the CORSAD Trial. Neonatology. 2023;120(2):250-256. doi: 10.1159/000528754. Epub 2023 Jan 23.
PubMed 36689927Donaldsson S, Drevhammar T, Li Y, Bartocci M, Rettedal SI, Lundberg F, Odelberg-Johnson P, Szczapa T, Thordarson T, Pilypiene I, Thorkelsson T, Soderstrom L, Chijenas V, Jonsson B; CORSAD Trial Investigators. Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks' Gestational Age: The CORSAD Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):911-918. doi: 10.1001/jamapediatrics.2021.1497.
PubMed 34125148
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks
- ClinicalTrials.gov ID
- NCT02563717
- Acronym / sponsor ID
- CORSAD / 2015/927-31/4
- Keywords
- Resuscitation, Positive-Pressure Respiration, Infant, Extremely Premature, Continuous Positive Airway Pressure, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Baldvin JonssonUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?
Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born <28 weeks.
Detailed description
The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.
The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.
During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.
Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.
After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.
The management of respiratory support is according to international guidelines and a detailed description is provided in the clinical management appendix. The intervention is respiratory support for the first 10-30 minutes of life and will begin after birth when the infant is transferred to the resuscitation team. The intervention ends 1) when an infant is intubated (primary outcome), 2) after a minimum of 10 minutes support, with the randomized system, the patient is stable and breathing adequately, 3) at 30 minutes when the respiratory support can continue as decided by the clinicians (cross-over not allowed).
Apart from the system used for respiratory support all patients will receive standard care. No assessments or investigations of the trial subjects are planned. Data will be reported by the resuscitation team and collected from records.
The primary outcome is delivery room intubation or death. The secondary outcomes include time to intubation, use of surfactant, use of positive pressure ventilation, respiratory support at 72 hours and temperature on intensive care admission. Safety variables include pneumothorax, intraventricular haemorrhage and problems with ventilation and equipment.
All analysis will be on intention to treat and p<0.05 considered statistically significant. The primary outcome variable (delivery room intubation or death) will represent a 2x2 cross table and analysed with Pearson chi-square test. The secondary outcomes include Kaplan Meier analysis of time to intubation and comparisons of means for continuous variables. There are no predetermined subgroups. Subgroup analysis will be used to describe the population and to generate hypotheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Device: T-piece System | Active comparator | Device: T-piece used for respiratory support (several manufacturers) |
| Investigational Device: The New System | Active comparator | Device: New system used for respiratory support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Born <28 weeks gestational age at a university hospital
- Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given
Key exclusion criteria (5 listed)
- Decision on treatment limitations before randomisation
- Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
- Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
- Known neuromuscular disease
- No study neonatologist available
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 |
|---|---|---|
| T-piece used for respiratory support (several manufacturers)Also: Neopuff™ Infant T-Piece Resuscitator, T-piece Disposable Circuit Kit (GE Healthcare), Other T-piece manufacturersInfants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol) | Device | Reference Device: T-piece System |
| New system used for respiratory supportAlso: Manufacturing and CE-marking by Inspiration Healthcare, UKInfants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol) | Device | Investigational Device: The New System |
Primary outcome
Delivery room intubation or death
Time frame: 0-30 minutes
The primary outcome is delivery room intubation or death. Death has to be included in the primary outcome since patients that die may not always be intubated. The variable is a dichotomous outcome and reported by the resuscitation team.
6 secondary outcomes
Time to primary outcome (intubation or death)
Time frame: up to 72 hours of age
Death
Time frame: up to 72 hours of age
Intra ventricular haemorrhage grade III or more
Time frame: up to 72 hours of age
Airleaks and pneumothorax
Time frame: up to 72 hours of age
Failed ventilation
Time frame: 0-30 minutes
Device problems or malfunction
Time frame: 0-30 minutes
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 1 Jun 2020.
- Derived from this study: PubMed 36689927Donaldsson S, Palleri E, Jonsson B, Drevhammar T. Transition of Extremely Preterm Infants from Birth to Stable Breathing: A Secondary Analysis of the CORSAD Trial. Neonatology. 2023;120(2):250-256. doi: 10.1159/000528754. Epub 2023 Jan 23.
- Derived from this study: PubMed 34125148Donaldsson S, Drevhammar T, Li Y, Bartocci M, Rettedal SI, Lundberg F, Odelberg-Johnson P, Szczapa T, Thordarson T, Pilypiene I, Thorkelsson T, Soderstrom L, Chijenas V, Jonsson B; CORSAD Trial Investigators. Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks' Gestational Age: The CORSAD Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):911-918. doi: 10.1001/jamapediatrics.2021.1497.
- Individual participant dataSharing planned: Undecided. Data will be shared but method of sharing not decided
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.
Baldvin Jonsson, MD, PhD principal investigator
Karolinska Institutet
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-piece used for respiratory support (several manufacturers) and New system used for respiratory support in people with Respiration; Insufficient or Poor, Newborn and Infant, Premature, Diseases, run by Baldvin Jonsson at 6 sites in 5 countries.
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 5 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Iceland, Lithuania, Norway, Poland. 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?
Delivery room intubation or death (time frame: 0-30 minutes). 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 NCT02563717, which also lists 2 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 1 Jun 2020.