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Neonatal Resuscitation With Supraglottic Airway Trial (NeoSupra)

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ClinicalTrials.gov Identifier: NCT03133572
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Makerere University
University of Padova
Karolinska Institutet
Doctors with Africa - CUAMM
Information provided by (Responsible Party):
Centre For International Health

Brief Summary:

Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A multi-centre randomized clinical trial will be conducted at Central Hospital, Beira, Mozambique and at Mulago Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.


Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Device: Supraglottic airway Device: Face-mask Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Day by day, infants will be randomized to either of the arms.
Masking: Single (Outcomes Assessor)
Masking Description: The neonatologists assessing the Thompson score will be blinded to the intervention arm. Other staff members will know about the arm allocation.
Primary Purpose: Treatment
Official Title: Neonatal Supraglottic Airway Trial: A Multi-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Actual Study Start Date : May 8, 2018
Actual Primary Completion Date : August 12, 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supraglottic airway
All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a supraglottic airway and a bag.
Device: Supraglottic airway
Instead of using a conventional face mask to provide positive pressure ventilation during neonatal resuscitation we are using a supraglottic airway and a conventional bag.
Other Names:
  • i-gel
  • supraglottic airway device

Active Comparator: Face-mask
All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a face-mask and a bag.
Device: Face-mask
In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.




Primary Outcome Measures :
  1. Composite outcome of either a) early neonatal death or b) neonatal encephalopathy [ Time Frame: Day 7 of life ]
    A composite outcome of a) early neonatal death (within 7 days) b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).


Secondary Outcome Measures :
  1. Number of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day 7 of life ]
    Safety of i-gel in the hands of non-doctor birth attendants (AEs and SAEs)

  2. Early neonatal death [ Time Frame: Day 7 of life ]
    Early neonatal death (within 7 days)

  3. Neonatal encephalopathy [ Time Frame: Day 7 of life ]
    Neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).

  4. Any hospital admission [ Time Frame: Day 7 of life ]
    Any hospital admission

  5. Time to start of positive pressure ventilation [ Time Frame: First 10 minutes ]
    Time to start of positive pressure ventilation

  6. Advanced resuscitation [ Time Frame: Day 7 of life ]
    Advanced resuscitation including intervention by supervising physician

  7. Time allocation during neonatal resuscitation [ Time Frame: First 10 minutes ]
    In a subgroup assess time used for stimulation, suction and ventilation during neonatal resuscitation

  8. Expired tidal volume [ Time Frame: First 10 minutes ]
    In a subgroup assess expired tidal volume (eTV)

  9. Mean airway pressure [ Time Frame: First 10 minutes ]
    In a subgroup assess mean airway pressure (MAP)

  10. mask leakage [ Time Frame: First 10 minutes ]
    In a subgroup assess mask leakage

  11. End-tidal carbon dioxide [ Time Frame: First 10 minutes ]
    In a subgroup assess end-tidal CO2 (ETCO2)

  12. Oxygen saturation [ Time Frame: First 10 minutes ]
    In a subgroup assess Oxygen Saturation (SO2), respiratory rate and heart rate 30-60-90-120 seconds

  13. Heart rate [ Time Frame: First 2 minutes ]
    In a subgroup assess heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inborn baby (=born in the hospital)
  • Expected > 34-week gestation
  • Expected birth weight > 2000 g
  • Need for PPV at birth
  • Parental consent

Exclusion Criteria:

  • Major malformations (incompatible with sustained life or affecting the airways)

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): NCT03133572


Locations
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Uganda
Mulago Teaching Hospital
Kampala, Uganda
Sponsors and Collaborators
Centre For International Health
Makerere University
University of Padova
Karolinska Institutet
Doctors with Africa - CUAMM
Investigators
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Principal Investigator: Thorkild Tylleskär, MD, PhD University of Bergen, Norway

Publications:
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Responsible Party: Centre For International Health
ClinicalTrials.gov Identifier: NCT03133572     History of Changes
Other Study ID Numbers: NeoSupra
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases