We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age (CORSAD)

This study is currently recruiting participants.
Verified October 2017 by Baldvin Jonsson, Karolinska Institutet
Sponsor:
ClinicalTrials.gov Identifier:
NCT02563717
First Posted: September 30, 2015
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Baldvin Jonsson, Karolinska Institutet
  Purpose

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.


Condition Intervention
Respiration; Insufficient or Poor, Newborn Infant, Premature, Diseases Device: T-piece used for respiratory support (several manufacturers) Device: New system used for respiratory support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Baldvin Jonsson, Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Time to primary outcome (intubation or death) [ Time Frame: up to 72 hours of age ]
    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.

  • Death [ Time Frame: up to 72 hours of age ]
    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.

  • Intra ventricular haemorrhage grade III or more [ Time Frame: up to 72 hours of age ]
    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.

  • Airleaks and pneumothorax [ Time Frame: up to 72 hours of age ]
    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.

  • Failed ventilation [ Time Frame: 0-30 minutes ]
    The number of patients with failed ventilation during resuscitation. Data reported by resuscitation team. This is a safety endpoint.

  • Device problems or malfunction [ Time Frame: 0-30 minutes ]
    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.


Other Outcome Measures:
  • Surfactant use in delivery room (DR) and neonatal intensive care unit (NICU) [ Time Frame: up to 72 hours of age ]
    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.

  • The use of positive pressure ventilation (PPV) in delivery room [ Time Frame: 0-30 minutes ]
    The number of patients that needed PPV during resuscitation. Data reported by resuscitation team.

  • Use of sustained inflation (not recommended) [ Time Frame: 0-30 minutes ]
    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.

  • Reason for DR intubation [ Time Frame: 0-30 minutes ]
    The main reason for intubating patients in the DR during resuscitation. Data reported by resuscitation team.

  • Response to resuscitation measured by APGAR at 1, 5 and 10 minutes [ Time Frame: 1-10 minutes ]
    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.

  • Inspired oxygen level, oxygen saturation (SpO2) and level of CPAP support at 5 and 10 minutes [ Time Frame: 5-10 minutes ]
    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.

  • Patient temperature on NICU admission [ Time Frame: 10-180 minutes ]
    The temperature of the patients when they arrive to NICU (°C). Data collected at patient record review of the first three days of life.

  • Reason for NICU intubation [ Time Frame: up to 72 hours of age ]
    The main reason for intubating patients in the NICU. Data collected at patient record review of the first three days of life.

  • Mechanical ventilation at any time <72 h [ Time Frame: up to 72 hours of age ]
    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.

  • Mechanical ventilation or mode of non-invasive support at 72 h [ Time Frame: at 72 hours of age ]
    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.

  • Decisions on treatment limitations during resuscitation [ Time Frame: 0-30 minutes ]
    The number of patients that had any decision on limitations of treatment during resuscitation. Data reported by resuscitation team.

  • Withdrawal or withholding treatment [ Time Frame: up to 72 hours of age ]
    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.


Estimated Enrollment: 250
Study Start Date: March 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference Device: T-piece System Device: T-piece used for respiratory support (several 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)
Other Names:
  • Neopuff™ Infant T-Piece Resuscitator
  • T-piece Disposable Circuit Kit (GE Healthcare)
  • Other T-piece manufacturers
Active Comparator: Investigational Device: The New System Device: New system used for respiratory support
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)
Other Name: Manufacturing and CE-marking by Inspiration Healthcare, UK

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Born <28 weeks gestational age at a university hospital
  2. Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given

Exclusion Criteria:

  1. Decision on treatment limitations before randomisation
  2. Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
  3. Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
  4. Known neuromuscular disease
  5. No study neonatologist available
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563717


Contacts
Contact: Snorri Donaldsson, MD +46-851776707 snorri.donaldsson@ki.se
Contact: Thomas Drevhammar, MD +46-701712361 thomas.drevhammar@regionjh.se

Locations
Lithuania
Neonatal Unit, Vilnius University Hospital Santaros Klinikos Not yet recruiting
Vilnius, Lithuania, LT-08406
Contact: Ingrida Pilypienė, MD, PhD    +37067299489    ingrida.pilypiene@santa.lt   
Contact: Virginija Sungailienė , MD    +37069816979    virginija.sungailiene@santa.lt   
Principal Investigator: Ingrida Pilypienė, MD, PhD         
Norway
Stavanger University Hospital, Department of Pediatrics Recruiting
Stavanger, Norway, 4011
Contact: Siren Rettedal, MD, PhD    +47-51518052    siren.irene.rettedal@sus.no   
Poland
Department of Neonatology, Poznan University of Medical Sciences Not yet recruiting
Poznan, Poland, 60-535
Contact: Tomasz Szczapa, MD, PhD    +48618419270    tszczapa@gmail.com   
Principal Investigator: Tomasz Szczapa, MD, PhD         
Sweden
University Hospital Linköping, Department of Pediatrics Recruiting
Linköping, Sweden, 58185
Contact: Fredrik Lundberg, MD, PhD         
Contact    +46-72-513 50 85    Fredrik.Lundberg@regionostergotland.se   
Karolinska University Hospital, Neonatology department Recruiting
Stockholm, Sweden, 171 76
Contact: Snorri Donaldsson, MD    +46700924156    snorri.donaldsson@karolinska.se   
Contact: Baldvin Jonsson, PhD    +46851775130    baldvin.jonsson@karolinska.se   
Principal Investigator: Snorri Donaldsson, MD         
Sponsors and Collaborators
Baldvin Jonsson
Investigators
Principal Investigator: Baldvin Jonsson, MD, PhD Karolinska Institutet
  More Information

Responsible Party: Baldvin Jonsson, Associate Professor and Clinical Director Karolinska University HospitalKarolinska University Hospital, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02563717     History of Changes
Other Study ID Numbers: 2015/927-31/4
First Submitted: September 24, 2015
First Posted: September 30, 2015
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared but method of sharing not decided

Keywords provided by Baldvin Jonsson, Karolinska Institutet:
Resuscitation
Positive-Pressure Respiration
Infant, Extremely Premature
Continuous Positive Airway Pressure
Intubation

Additional relevant MeSH terms:
Infant, Premature, Diseases
Infant, Newborn, Diseases