Neonatal Resuscitation With Supraglottic Airway Trial (NeoSupra)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03133572|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : September 26, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1163 participants|
|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.|
|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|
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.
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.
In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.
- 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).
- 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)
- Early neonatal death [ Time Frame: Day 7 of life ]Early neonatal death (within 7 days)
- 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).
- Any hospital admission [ Time Frame: Day 7 of life ]Any hospital admission
- Time to start of positive pressure ventilation [ Time Frame: First 10 minutes ]Time to start of positive pressure ventilation
- Advanced resuscitation [ Time Frame: Day 7 of life ]Advanced resuscitation including intervention by supervising physician
- Time allocation during neonatal resuscitation [ Time Frame: First 10 minutes ]In a subgroup assess time used for stimulation, suction and ventilation during neonatal resuscitation
- Expired tidal volume [ Time Frame: First 10 minutes ]In a subgroup assess expired tidal volume (eTV)
- Mean airway pressure [ Time Frame: First 10 minutes ]In a subgroup assess mean airway pressure (MAP)
- mask leakage [ Time Frame: First 10 minutes ]In a subgroup assess mask leakage
- End-tidal carbon dioxide [ Time Frame: First 10 minutes ]In a subgroup assess end-tidal CO2 (ETCO2)
- Oxygen saturation [ Time Frame: First 10 minutes ]In a subgroup assess Oxygen Saturation (SO2), respiratory rate and heart rate 30-60-90-120 seconds
- Heart rate [ Time Frame: First 2 minutes ]In a subgroup assess heart rate
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
|Mulago Teaching Hospital|
|Principal Investigator:||Thorkild Tylleskär, MD, PhD||University of Bergen, Norway|