Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age (CORSAD)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Reykjavík, IJsland, 101
- Department of neonatology, University Hospital of Iceland
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Vilnius, Litouwen, LT-08406
- Neonatal Unit, Vilnius University Hospital Santaros Klinikos
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Stavanger, Noorwegen, 4011
- Stavanger University Hospital, Department of Pediatrics
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Poznan, Polen, 60-535
- Department of Neonatology, Poznan University of Medical Sciences
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Linköping, Zweden, 58185
- University Hospital Linköping, Department of Pediatrics
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Stockholm, Zweden, 171 76
- Karolinska University Hospital, Neonatology department
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Reference Device: T-piece System
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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)
Andere namen:
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Actieve vergelijker: Investigational Device: The New System
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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)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Delivery room intubation or death
Tijdsspanne: 0-30 minutes
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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.
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0-30 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to primary outcome (intubation or death)
Tijdsspanne: up to 72 hours of age
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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.
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up to 72 hours of age
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Death
Tijdsspanne: up to 72 hours of age
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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.
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up to 72 hours of age
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Intra ventricular haemorrhage grade III or more
Tijdsspanne: up to 72 hours of age
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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.
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up to 72 hours of age
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Airleaks and pneumothorax
Tijdsspanne: up to 72 hours of age
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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.
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up to 72 hours of age
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Failed ventilation
Tijdsspanne: 0-30 minutes
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The number of patients with failed ventilation during resuscitation.
Data reported by resuscitation team.
This is a safety endpoint.
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0-30 minutes
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Device problems or malfunction
Tijdsspanne: 0-30 minutes
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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.
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0-30 minutes
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Surfactant use in delivery room (DR) and neonatal intensive care unit (NICU)
Tijdsspanne: up to 72 hours of age
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The number of patients, method used and the number of doses that a patient received in the DR and NICU.
Data reported by resuscitation team or collected at patient record review of the first three days of life.
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up to 72 hours of age
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The use of positive pressure ventilation (PPV) in delivery room
Tijdsspanne: 0-30 minutes
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The number of patients that needed PPV during resuscitation.
Data reported by resuscitation team.
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0-30 minutes
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Use of sustained inflation (not recommended)
Tijdsspanne: 0-30 minutes
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The number of patients that were treated with a sustained inflation during resuscitation.
This is not recommended and a violation of protocol.
Data reported by resuscitation team.
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0-30 minutes
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Reason for DR intubation
Tijdsspanne: 0-30 minutes
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The main reason for intubating patients in the DR during resuscitation.
Data reported by resuscitation team.
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0-30 minutes
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Response to resuscitation measured by APGAR at 1, 5 and 10 minutes
Tijdsspanne: 1-10 minutes
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The initial status of the patient and response to resuscitation measured by APGAR-scores (0-2 points on the five standard criteria).
Data reported by resuscitation team.
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1-10 minutes
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Inspired oxygen level, oxygen saturation (SpO2) and level of CPAP support at 5 and 10 minutes
Tijdsspanne: 5-10 minutes
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The initial status of the patient and response to resuscitation measured by need for oxygen (%), SpO2 (%) and the level of CPAP support (cm H2O).
Data reported by resuscitation team.
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5-10 minutes
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Patient temperature on NICU admission
Tijdsspanne: 10-180 minutes
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The temperature of the patients when they arrive to NICU (°C).
Data collected at patient record review of the first three days of life.
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10-180 minutes
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Reason for NICU intubation
Tijdsspanne: up to 72 hours of age
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The main reason for intubating patients in the NICU.
Data collected at patient record review of the first three days of life.
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up to 72 hours of age
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Mechanical ventilation at any time <72 h
Tijdsspanne: up to 72 hours of age
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The number of patients that has received mechanical ventilation at any time <72 hours.
Data collected at patient record review of the first three days of life.
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up to 72 hours of age
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Mechanical ventilation or mode of non-invasive support at 72 h
Tijdsspanne: at 72 hours of age
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The number of patients that had mechanical ventilation or non-invasive support at three days of age (including type of support).
Data collected at patient record review of the first three days of life.
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at 72 hours of age
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Decisions on treatment limitations during resuscitation
Tijdsspanne: 0-30 minutes
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The number of patients that had any decision on limitations of treatment during resuscitation.
Data reported by resuscitation team.
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0-30 minutes
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Withdrawal or withholding treatment
Tijdsspanne: up to 72 hours of age
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The number of patients that had any decision on withdrawal or withholding treatment in the DR or NICU.
Data collected at patient record review of the first three days of life.
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up to 72 hours of age
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Baldvin Jonsson, MD, PhD, Karolinska Institutet
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015/927-31/4
Plan Individuele Deelnemersgegevens (IPD)
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